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      • abstract_of_study<p>\n <strong><u>Trial Design:</u></strong></p>\n<p>\n This is a Phase III multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of crizanlizumab 5 mg/kg versus placebo, with or without concurrent HU/HC therapy in patients with SCD who experience frequent VOCs (4-12 events in the 12 months prior to the screening visit).</p>\n<p>\n <strong><u>Purpose of the study:</u></strong></p>\n<p>\n The main purpose of this study is to determine whether crizanlizumab may reduce the number of VOCs when compared to placebo, with or without standard of care medications in adolescent and adult SCD patients with frequent VOCs leading to healthcare visits. The study duration will be approximately 2 years.</p>\n<p>\n <strong><u>Study Rationale:</u></strong></p>\n<p>\n Crizanlizumab was first approved in the USA (BLA 761128) under the trade name Adakveo® on 15-Nov-2019. This BLA approval was based on the results from the Phase II Study CSEG101A2201 (SUSTAIN), a 52-week, randomized, placebo-controlled study (N=198) of crizanlizumab 2.5 and 5 mg/kg. In Study A2201, a vasoocclusive crises (VOC) was defined as an acute episode of pain with no other cause than a vasoocclusion, which required a visit to a medical facility and treatment with oral or parenteral opioids or parenteral non-steroidal anti-inflammatory drugs (NSAIDs). This included both uncomplicated VOCs as well as complicated VOCs such as acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism. These visits required a visit to a medical facility. An uncomplicated crisis was defined as a VOC that was not classified as acute chest syndrome, hepatic sequestration, splenic sequestration, priapism, and which did not lead to death.</p>\n<p>\n Treatment with crizanlizumab 5 mg/kg in Study A2201 resulted in a median annual rate of VOCs leading to a healthcare visit that was 45.3% lower than the median annual rate with placebo, which was statistically significant (p=0.010). The median annual rate of uncomplicated crises and median number of days hospitalized were 62.9% and 41.8% lower than in the placebo group, respectively. These constitute meaningful reductions in the frequency of VOCs and hospitalizations that can be expected to have a significant impact on quality of life (QoL), morbidity and mortality in patients with SCD.</p>\n<p>\n Study CSEG101A2301 is an ongoing Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of two doses of crizanlizumab (5 mg/kg and 7.5 mg/kg) versus placebo, with or without hydroxyurea/ hydroxycarbamide therapy (HU/HC), in adolescent and adult patients with SCD. VOC was defined the same way as previously noted in the SUSTAIN trial.</p>\n<p>\n In Dec-2022, the results of the primary analysis of Study CSEG101A2301 did not show evidence of superiority of either dose of crizanlizumab (5 mg/kg or 7.5 mg/kg) over placebo on the primary or key secondary endpoints and therefore are not consistent with the results from Study CSEG101A2201.</p>\n<p>\n While the endpoint of VOC leading to a healthcare visit reflects a key aim of treatment in SCD, i.e., prevention/reduction of VOCs, it is important to note that it is dependent on patients making the decision to go or not go to the hospital. The different results in Study CSEG101A2301 compared with Study CSEG101A2201 could be due to various factors/differences between the studies, including but not limited to:</p>\n<ol style=\"list-style-type:lower-roman;\">\n <li value=\"5\">\n The impact of the COVID-19 global pandemic, which may have caused a masking effect/reduction in reporting of VOCs as well as a potential reduction in triggers for VOCs in Study CSEG101A2301.\n <ol style=\"list-style-type:lower-roman;\">\n <li value=\"5\">\n Differences in the geographic location of participating patients, thereby factoring in the differences in healthcare utilization: patients were located primarily in the USA in Study CSEG101A2201 vs. globally dispersed in Study CSEG101A2301.</li>\n </ol>\n </li>\n</ol>\n<p>\n Thus, while the initial randomized, placebo-controlled trial (Study CSEG101A2201), the open label studies (Study SEG101A2202, Study SEG101B2201 and Study SEG101AUS05) and real-world data (MAP data and registries) have all demonstrated clinical benefit with crizanlizumab, the second, randomized, placebo-controlled Study CSEG101A2301 did not.</p>\n<p>\n The current study (Study CSEG101A2303; hereafter referred to as Study A2303), a randomized, placebo-controlled Phase III study, was developed to overcome the uncertainties raised by the conflicting results of Studies CSEG101A2301 and CSEG101A2201. The purpose of this study is to compare the efficacy of crizanlizumab (5 mg/kg) versus placebo, with or without HU/HC in adolescent and adult SCD patients with frequent VOCs (4 to 12 per year) that are Health care practitioner-managed (including VOCs leading to management at a health care facility or those managed via remote consultation).</p>\n<p>\n Data from this study will be used to evaluate the effect of crizanlizumab versus placebo, with or without concurrent HU/HC therapy, on VOC rate in SCD patients aged 12 years and older who experience frequent VOCs.</p>\n<p>\n <strong><u>Study Population:</u></strong></p>\n<p>\n The study will include participants aged 12 years and older with confirmed diagnosis of SCD (all genotypes are eligible) who have experienced at least 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Participants may receive HU/HC as a standard of care.</p>\n<p>\n This study plans to enroll 315 participants. Participants will be randomized in a 2:1 ratio to the crizanlizumab 5 mg/kg or placebo treatment arm (see Section 9.9 of the Protocol v00 for more details on sample size determination).</p>\n
      • study_title<p>\n A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises</p>\n
      • laymans_summary<div>\n  Sickle cell disease is one of the most common blood disease in the world that is passed down from generation to another and is characterized by frequent pain episodes, reduced blood levels as well as multiple organ damage. Painful episodes are the most common presentation of sickle cell disease. These are caused by activation of different components of blood triggered by the sickled red blood cells. The activation of these blood components leads to their expression of the p-selectin molecule found in blood which promotes sticking together of cells to each other resulting in blockage of blood vessels. Painful episodes are a clinical hallmark of SCD and cause considerable acute and chronic reduction in quality of life as well as death. L-glutamine and Hyrdoxyurea have been approved by the food and drug administration to reduce VOCs in patients with SCD. Crizanlizumab is a potent and selective IgG2 (immunoglobulin G2) kappa humanized monoclonal antibody that binds to human P-selectin with high affinity, blocking its interaction with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Extensive pre-clinical data have established P-selectin as a key mediator of VOC in SCD (Matsui et al 2001) and suggest that blockade of P-selectin could eliminate or reduce VOC. </div>\n<div>\n  </div>\n<div>\n This study is a drug clinical trial sponsored by Norvatis Research and Development and is to be implemented at KEMRI CRDR Siaya Clinical Research Annex by Professor Videlis Nduba as the Principal Investigators alongside Dr. Mercy Mwale and Dr. Mike Odoyo as the Sub-investigators. This study will be conducted in many sites globally in a randomized manner where a participant will either get inactive or active form of treatment as assigned by the Investigator or designee through a system generated method provided by sponsor. Both the participants as well as the study staff will not know the treatment administered to the participant. </div>\n<div>\n  </div>\n<div>\n It is a Phase 3 study comparing crizanlizumab 5 mg/kg to inactive form of treatment with or without simultaneous use of Hydroxyurea/Hydroxycarbamide treatment in adolescent and  adult SCD patients who experience frequent painful episodes. The study will include participants aged 12 years and older with confirmed diagnosis of SCD (all variants of sickle cell disease are eligible) who have experienced at least 4-12 painful episodes that are Healthcare professional-managed (including painful episodes leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Participants may receive Hydroxyurea/Hydroxycarbamide  as standard of care. </div>\n<div>\n  </div>\n<div>\n Globally 315 participants will be enrolled. Kenya has been allocated 30 participants to be competitively enrolled among 6 sites sites which are: Getrude’s Children’s Hospital; International Cancer Institute; KEMRI Kondele Children’s Hospital; CREATES Ahero Clinical Ahero and Victoria Biomedical Research. Therefore, at least 5 participants will be enrolled by the Siaya site. For every 3 participants enrolled into the study, 2 will receive crizanlizumab 5mg/kg whereas 1 will receive the inactive form of treatment. Central assignment of the treatment arm will be grouped according to simultaneous Hydroxyurea/Hydroxycarbamide usage (yes/no) and region (South America, North America, and sub- Saharan Africa) at baseline. There is a potential side effect of infusion related reaction with the administration of crizanlizumab that has been observed so far. </div>\n<div>\n  </div>\n<div>\n Data from this study will be used to evaluate the effect of crizanlizumab versus inactive form of treatment, with or without concurrent Hydroxyurea/Hydroxycarbamide treatment, on painful episodes rate in SCD patients aged 12 years and older who experience frequent painful episodes. The study will be conducted according to the protocol, guidelines established by the ICH for GCP in clinical studies. The study protocol, informed consent forms, electronic case report forms and site specific protocol will be submitted to the regulatory bodies as required, and once approval is received from the Ethics Committee and Pharmacy and Poisons Board of Kenya , the site will be initiated and activated. </div>\n<div>\n  </div>\n<div>\n  </div>\n
      • short_titleSparkle - Site 1405
      • protocol_noECCT/25/03/07
      • version_no00
      • date_of_protocol02-02-2024
      • study_drugCrizanlizumab
      • disease_conditionSickle Cell Disease
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameNot Applicable
      • comparator_registeredNot Applicable
      • comparator_countriesNot Applicable
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressraps.clinicaltrials@novartis.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
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      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
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      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDenish Kineni
      • declaration_date130-03-2025
      • declaration_principal_investigatorProf Videlis Nduba
      • declaration_date230-03-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).</p>\n<p>\n <strong>Secondary Objective:</strong></p>\n<ul>\n <li>\n To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52- week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).</li>\n <li>\n To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:</li>\n</ul>\n<ol style=\"list-style-type:lower-roman;\">\n <li value=\"5\">\n VOCs that are HCP-managed at a health care facility\n <ol style=\"list-style-type:lower-roman;\">\n <li value=\"5\">\n VOCs that are HCP-managed via remote consultation</li>\n <li value=\"5\">\n VOCs that are self-managed without recommendations from HCP during the event</li>\n </ol>\n </li>\n <li value=\"5\">\n VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event</li>\n</ol>\n<ul>\n <li>\n To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</li>\n <li>\n To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</li>\n <li>\n To evaluate the duration of VOCs that are HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</li>\n <li>\n To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study period.</li>\n</ul>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<ul>\n <li>\n To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.</li>\n <li>\n To explore the proportion of VOCs that are self-managed without recommendations from HCP during the event, versus VOCs that are HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.</li>\n <li>\n To explore the proportion of VOCs that are HCP managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52- week treatment period.</li>\n <li>\n To explore the incidence rates of all VOCs, VOCs that are HCP-managed at a healthcare facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed, VOCs that are self-managed without recommendations from HCP during the event, VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event, by treatment arm.</li>\n <li>\n To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).</li>\n</ul>\n<ul>\n <li>\n To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit) between treatment arms over the planned 52- week treatment period.</li>\n <li>\n To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.</li>\n <li>\n To explore the pharmacodynamics (PD) (P selectin inhibition) of crizanlizumab at 5 mg/kg.</li>\n <li>\n To explore biomarkers [p-selectin (free and total)] and CRP].</li>\n <li>\n To explore exposure-response relationship</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong><u>Principal Inclusion Criteria:</u></strong></p>\n<p>\n 1. Signed informed consent must be obtained prior to participation in the study.</p>\n<p>\n 2. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older.</p>\n<p>\n 3. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.</p>\n<p>\n 4. Experienced 4 to 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.</p>\n<p>\n Prior VOCs that were HCP-managed at a health care facility or managed via remote consultation must have resolved at least 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 5. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.</p>\n<p>\n Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.</p>\n<p>\n 6. Participants must meet the following central laboratory values prior to Week1 Day 1. In case re-sampling is needed, local laboratory values are allowed.</p>\n<ol style=\"list-style-type:lower-roman;\">\n <li value=\"5\">\n Absolute Neutrophil Count ≥1.0 x 109/L</li>\n <li value=\"5\">\n Platelet count ≥75 x 109/L</li>\n <li value=\"5\">\n Hemoglobin: for adults (Hb) ≥5.0 g/dL and for adolescents (Hb) ≥5.5 g/dL</li>\n <li value=\"5\">\n Glomerular filtration rate ≥45 mL/min/1.73 m2 based on CKD-EPI formula (patients ≥18), or the Creatinine-based “Bedside Schwartz” equation (patients <18)</li>\n <li>\n Direct (conjugated) bilirubin ≤3.0 x ULN</li>\n <li value=\"5\">\n Alanine transaminase (ALT) <3.0 x ULN</li>\n</ol>\n<p>\n 7. Score of 50% or higher on the Karnofsky Performance Scale at screening.</p>\n<p>\n 8. Received standard age-appropriate care for SCD, including an up-to-date record of immunizations, as per local requirements.</p>\n
      • principal_exclusion_criteria<p>\n <strong><u>Principal Exclusion Criteria:</u></strong></p>\n<p>\n Participants meeting any of the following criteria are not eligible for inclusion in this study.</p>\n<p>\n 1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.</p>\n<p>\n 2. History of stem cell transplant and/or gene therapy.</p>\n<p>\n 3. Received blood products within 30 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.</p>\n<p>\n 5. Clinically significant bleeding disorder.</p>\n<p>\n 6. Use of therapeutic anticoagulation or antiplatelet therapy (other than aspirin or NSAIDs) within the 10 days prior to Week 1 Day 1 dosing. Note: Prophylactic anticoagulant dose is permitted, as per local guidelines.</p>\n<p>\n 7. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.</p>\n<p>\n 8. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.</p>\n<p>\n 9. Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial.</p>\n<p>\n 10. Participants of child-bearing potential who are or might become sexually active, must be informed of the potential teratogenic risk with crizanlizumab and the need for highly effective contraception methods to prevent pregnancy while on crizanlizumab therapy. Any participant with the biologic potential to become pregnant must agree to the use of oral, injected or implanted hormonal methods of</p>\n<p>\n contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception is required if sexually active. Patients should also follow other guidelines for contraception in the setting of other standard of care therapies. Contraception must be used during the study and for 15 weeks after stopping treatment. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.</p>\n<p>\n 11. Pregnant females or females who have given birth within the past 90 days or who are breastfeeding.</p>\n<p>\n 12. Planning to undergo a major surgical procedure during the duration of the study.</p>\n<p>\n 13. Hospitalized within 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 14. Acute VOCs ending within 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 15. Participants with active HIV infection (detectable viral load) at screening.</p>\n<p>\n 16. Participants with active Hepatitis B infection (HBsAg positive) at screening. Note: Participants with antecedent but no active Hepatitis B (i.e., anti-HBs positive, HBsAg and HBV-DNA negative) are eligible.</p>\n<p>\n 17. Positive test for hepatitis C ribonucleic acid (HCV RNA) at screening. Note: Participants in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those that achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA ≥6 months (with the use of IFN-free regimes) or ≥12 months (with the use of IFN-based regimes) after cessation of antiviral treatment are eligible.</p>\n<p>\n 18. Malignant disease. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 3 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.</p>\n<p>\n 19. Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the investigator, could cause unacceptable safety risks or compromise participation in the study.</p>\n<p>\n 20. Any condition which, in the opinion of the investigator, is likely to interfere with the successful collection of the measurements required for the study. This can include inability to understand and comply with study instructions and requirements.</p>\n<p>\n 21. Received prior treatment with crizanlizumab or other selectin targeting agent or plans to receive these therapies outside of the study during the duration of the study.</p>\n<p>\n 22. Use of HA approved form(s) of L-glutamine within 6 months of screening or plans to receive it during the study.</p>\n<p>\n 23. Currently on voxelotor or received voxelotor within 6 months of screening or plans to receive it during the study.</p>\n<p>\n 24. Participants taking prohibited therapies </p>\n
      • primary_end_points<p>\n <strong><u>Primary Endpoint:</u></strong></p>\n<p>\n Annualized rate of VOCs that are HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm over the planned 52-week treatment period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyBiomarkers
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>Site 1405</u></strong>:</p>\n<p>\n KEMRI/CRDR Siaya Clinical Research Center:</p>\n<p>\n Kenya Medical Research Institute-Centre for Respiratory Disease Research (KEMRI/CRDR) Siaya Site is located within Siaya County Referral hospital in Siaya County, Western Kenya, about 67-74 (Route dependent) KM from Kisumu City. KEMRI CRDR has been in operation since its inception in 2007. It is part of the larger KEMRI which is a state corporation established through since and technology (Amendment) ACT of 1979. KEMRI has gradually grown over 40 years to become the national leading institute in clinical human health research. Our mission is to improve human health and quality of life through research, capacity building, innovation and service delivery.</p>\n<p>\n <strong>Staffing Structure:</strong></p>\n<p>\n The research activities at the KEMRI/CRDR are under the overall leadership of Prof Videlis Nduba, assisted by the delegated Sub-Investigators who are medical doctors. The site leadership is organized as per the organogram below, figure 1 whereby each department has a section leader who reports to the delegated sub-investigators doubling up as study coordinators at the site and sub-investigator reports to the PI.</p>\n<p>\n The site duties and responsibilities for the protocol implemented at the site are assigned to key study staff as appropriate, based on background, training, and experience. All study staff work on the various protocols being implemented at the site and report to section leads; however, each protocol has a study champion to ensure full compliance with all protocols as well as regulatory requirements, such coordination ensures sustainability and cost-effective use of available resources while avoiding waste or redundant parallel facilities.</p>\n<p>\n The research team meets every week and ad hoc to discuss research activities of the previous week, including protocol visits and safety issues, challenges or concerns, quality control findings, laboratory activities and community updates. These meetings also act as a platform for training, discussing regulatory updates, planning research activities and continuous medical education in disease of interest.</p>\n<p>\n The site has a total of approximately 43 staff, including the principal Investigator, 2 Sub Investigators, 4 Clinical Officers, 2 Pharmacists, 1 pharmaceutical Technologist, 5 Laboratory technologists, 6 Nurses, 4 Data Officers, 3 Drivers, 8 Community Engagement Officers, 6 QA/QC Officers including the regulatory office, 1 administrative officer and 1 receptionist.</p>\n<p>\n <strong>Experience:</strong></p>\n<p>\n The site has experienced research staff cutting across different studies in different networks, with the distribution of staff full time -equivalents across the different studies. Some of the study personnel have a wealth of experience of more than 10 years in clinical research. This allows for continuity and shared experiences by having staff engaged throughout the research portfolio across different studies and cohorts.</p>\n<p>\n The study team is trained on standard operating procedures, study protocol, and study manuals before conducting study procedures, ensuring the site complies with the protocol, Regulatory, IRB and GCP Guidelines.</p>\n<p>\n All study staff are human subjects’ protection and good clinical practice certified. All laboratory staff are good clinical laboratory Practice and IATA certified, and the community engagement team are Good Participatory Practice trained.</p>\n<p>\n Since 2007, the site has gained experience conducting research activities across diverse age cohorts and various vaccine and therapeutic areas in disease such as malaria, sickle cell disease, TB, Marburg, Ebola , Covid 19 etc.</p>\n<p>\n <strong><u>Facilities and Equipment:</u></strong></p>\n<p>\n The site is a modern research facility that is well equipped with the capacity to conduct Phase I-IV studies of all age groups. The site has a dedicated research space with patient assessment and examination rooms, an on-site drug storage are the site pharmacy (which is access and temperature controlled) an on-site laboratory area, a crash cart that is fully equipped with emergency medication,a secure fireproof and access-controlled area for archiving of documents, monitoring office rooms to accommodate monitors , auditors or inspectors and a stable internet and IT support.</p>\n<p>\n The research clinic is also laced within the referral hospital, a level 5 health facility. This strategic location and collaboration allow feasible referral of participants who require special services, and it is primary source of participants for hospital-based clinical trials.</p>\n<p>\n <strong><u>Patent Recruitment & Retention:</u></strong></p>\n<p>\n For SCD clinical trials, the site maintains a database of people living with SCD, the database was generated from welfare and support groups of SCD patients, snowballing, referrals from health facilities and participants who participated in previous studies.</p>\n<p>\n The site has maintained outstanding performance ratings on enrolment and retention based on sponsor monitoring reports.</p>\n<p>\n <strong><u>Quality assurance policies and protocols:</u></strong></p>\n<p>\n The principal Investigator maintains overall responsibility for protocol compliance. He provides overall study oversight and delegates some duties to key study personnel, sub-investigators and section leads to assist in implementing the study protocols at the site.</p>\n<p>\n Quality Assurance ensures protocols are implemented at the site in compliance with good clinical practice, regulatory requirements, sponsor guidelines, and internal standard operating procedures. The primary objective is to maintain high-quality data integrity subject safety, and protocol adherence.</p>\n<p>\n The quality team ensures all sites personnel undergo mandatory GCP and study-specific training before trial initiation. Training records are maintained in the site training logs. Continuous training updates are provided when protocol amendments or regulatory changes occur.</p>\n<p>\n Non-compliance and deviations are assessed and reported to the sponsor and IRB/IEC per regulatory requirements and corrective action plans are implemented to prevent recurrence.</p>\n<p>\n The site does pre-audit or pre-inspection self-assessment to ensure compliance and always strives to be audit or inspection ready. Essential documents are maintained per ICH-GCP guidelines. Archival and Retention policies such as the archival SOP are in place to ensure proper storage of clinical trial records for the required period.</p>\n<p>\n In QC procedure for study visits, a 100% two-tiered quality control process is performed on all study records and 25% on the 3^rd level on randomly selected binders. Focus is put on ensuring that all requisite data is collected and procedures stipulated for each study visit are completed as appropriate. The staff performing study procedures does 100% first-level QC, ensuring that all procedures are done and documented appropriately; this process is captured in the source document worksheet used to collect data (this process is done before the participant moves to the next stage as applicable). The delegated QA/QC officer does real-time 100% second-level quality checks in between procedures, ensuring that all procedures are done and documented well.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span style=\"font-size: 10pt; line-height: 107%; font-family: Calibri, sans-serif; color: black; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">Switzerland is the host country of the Sponsor however the study will not be conducted in the host country because the birth incidence of disease is far lower in Switzerland than in Kenya.</span></p>\n
      • other_details_regulatory_notapproved<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n  </p>\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Brazil</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Agência Nacional de Vigilância Sanitária  - ANVISA</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 10-May-2024</p>\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Colombia</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Instituto de Vigilancia de Medicamentos y Alimentos INVIMA</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 09-Jul-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Ghana</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Food and Drug Authority (FDA) Ghana</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 28-Feb-2025</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Kenya</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Pharmacy and Poisons Board (PPB)</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Initial iCTA: 13Nov2024 (Only site 1401 was submitted with the initial clinical trial application)</p>\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Nigeria</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n National Agency for Food and Drug Administration and Control</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 28-Feb-2025</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Tanzania</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY (TMDA)</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 21-Feb-2025</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Uganda</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n National Drug Authority (NDA)</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 20-Feb-2025</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Zambia</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Zambia Medicines Regulatory Authority ZAMRA</p>\n <p align=\"center\">\n  </p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Planned</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n United States</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n U.S. Food and Drug Administration</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 06-Mar-2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n United States – Silent Approval_20 Sites in the US</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"0\">\n <tbody>\n <tr>\n <td style=\"width:68px;height:20px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:128px;height:20px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:112px;height:20px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n <td style=\"width:123px;height:20px;\">\n <p align=\"center\">\n <strong>Approval date</strong></p>\n </td>\n <td style=\"width:181px;height:20px;\">\n <p align=\"center\">\n <strong>Number of sites </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:68px;height:20px;\">\n <p align=\"center\">\n Colombia </p>\n </td>\n <td style=\"width:128px;height:20px;\">\n <p align=\"center\">\n Instituto de Vigilancia de Medicamentos y Alimentos INVIMA </p>\n </td>\n <td style=\"width:112px;height:20px;\">\n <p align=\"center\">\n 09-Jul-2024 </p>\n </td>\n <td style=\"width:123px;height:20px;\">\n <p align=\"center\">\n 11-December-2024 </p>\n </td>\n <td style=\"width:181px;height:20px;\">\n <p align=\"center\">\n 4 Sites </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n No Rejections received to date</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_durationapproximately 2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNot Applicable
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites6 sites anticipated in Kenya. Kindly note that this application is for site 1405. Site 1401 was submitted to KPPB as part of the iCTA on the 13th of November 2024
      • multi_country_listBrazil\nColombia\nGhana\nKenya\nNigeria\nUganda\nTanzania\nZambia\nUnited States
      • data_monitoring_committeeNo
      • total_enrolment_per_siteMin 5 maximum 15 across 6 sites
      • total_participants_worldwide315 participants
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBchB, MPH, PHD
      • investigator1_professional_addressKEMRI/CRDR Siaya Clinical Research Annex, KEMRI Clinical Research Annex -Siaya County Referral Hospital Grounds. Siaya Kenya
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants60
      • notification
      • approval_date16-09-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-03-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted30-03-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-09-16 13:30:10
      • created2025-03-28 09:23:28
      • total_sites1
      • ecitizen_invoice363974
    • InvestigatorContact(array)
      • 0(array)
        • id1245
        • application_id1529
        • given_nameProf Videlis
        • middle_name
        • family_nameNduba
        • qualificationMBchB, MPH, PHD
        • professional_addressKEMRI/CRDR Siaya Clinical Research Annex, Siaya County Referral Hospital Grounds, PO Box 144-4600 Siaya Kenya
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2025-03-28 09:23:28
        • modified2025-05-19 12:18:56
    • SiteDetail(array)
      • 0(array)
        • id1863
        • application_id1529
        • county_id41
        • site_nameKEMRI/CRDR KEMRI Clinical Research Annex
        • physical_addressKEMRI Clinical Research Annex -Siaya County Referral Hospital Grounds. Siaya Kenya
        • contact_details+254724522474 PO Box 144-4600
        • contact_personProf Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2025-03-28 10:00:41
        • modified2025-05-19 12:18:56
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id1869
        • application_id1529
        • county_id42
        • site_nameAhero Clinical trials Unit
        • physical_addressAhero County Hospital.
        • contact_detailsP.O Box 54- 40100 Kisumu Kenya,Along Nairobi Kisumu Highway
        • contact_personProf Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2025-03-30 10:40:23
        • modified2025-05-19 12:18:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1870
        • application_id1529
        • county_id27
        • site_nameInternational Cancer institute
        • physical_addressInternational Cancer Institute
        • contact_detailsP.O Box 8088-30100 Eldoret Kenya
        • contact_personProf Fredrick Chite
        • site_capacity(null)
        • misc(null)
        • created2025-03-30 10:40:23
        • modified2025-05-19 12:18:56
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1871
        • application_id1529
        • county_id42
        • site_nameKondele Childrens Hospital
        • physical_addressKEMRI Kondele Childrens Hospital within Jaramogi Oginga Odinga Teaching and Referral Hospital Along Kisumu Kakamega Road.
        • contact_detailsPo Box 54-40100 Kisumu kenya
        • contact_personDr Allan Godfrey Otieno
        • site_capacity(null)
        • misc(null)
        • created2025-03-30 10:40:23
        • modified2025-05-19 12:18:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1872
        • application_id1529
        • county_id47
        • site_nameGertrudes Children’s Hospital
        • physical_addressGertrude’s Children’s Hospital, Muthaiga,
        • contact_detailsPO Box 42325-00100 Nairobi kenya
        • contact_personDr Doreen Karimi Mutua
        • site_capacity(null)
        • misc(null)
        • created2025-03-30 10:40:23
        • modified2025-05-19 12:18:56
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 5(array)
        • id1873
        • application_id1529
        • county_id42
        • site_nameVictoria Biomedical Research Institute
        • physical_addressVictoria Biomedical Research Institute, Kisumu County Referral Hospital,
        • contact_detailsP.O. Box 7180-40100, Kisumu, Kenya
        • contact_personDr Lucas Tina
        • site_capacity(null)
        • misc(null)
        • created2025-03-30 10:40:23
        • modified2025-05-19 12:18:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id821
        • application_id1529
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personCelia Huang
        • addressNovartis Campus Lichtstrasse 35 4056 Basel Switzerland
        • telephone_number+41 (79) 9117238
        • fax_numberNot applicable
        • cell_number+41 (79) 9117238
        • email_addresscelia.huang@novartis.com
        • created2025-03-28 10:00:41
        • modified2025-05-19 12:18:56
  • 1(array)
    • Application(array)
      • id1396
      • user_id729
      • trial_status_id7
      • abstract_of_study<p>\n Measles is one of the most contagious diseases for humans. It is caused by a paramyxovirus virus, manifesting as a febrile illness with rash.1 Initial symptoms (prodrome) generally consist of fever, malaise, cough, conjunctivitis, and coryza appear 10-12 days after infection. The characteristic maculopapular rash appears two to four days after onset of the prodrome. Measles complications such as pneumonia, diarrhea and encephalitis can occur in up to 30% of persons depending on age and predisposing conditions, such as young age, malnutrition and immunocompromising conditions. Measles can infect anyone of any age, but most of the burden of disease globally is still among children < 5 years of age. There is no specific antiviral treatment against the measles virus. Measles can be prevented by immunization. The measles vaccine is a live attenuated virus vaccine which is available since 1963; two doses are recommended by WHO to provide protection from disease. Accelerated immunization activities have had a major impact on reducing measles deaths including Kenya. Post introduction of vaccine global measles deaths have decreased by 73% from an estimated 536 000 in 2000 to 142,000 in 2018. During 2000– 2018, measles vaccination prevented an estimated 23.2 million deaths.2All six WHO regions had a measles elimination goals by or before 2020, and surveillance was considered a key element to achieve elimination.3 Mumps is an infectious viral disease transmitted via respiratory droplets, fomites, or personal contact. Symptoms often begin with chilly sensations, headache, loss of appetite, feeling of not being well and fever. Once symptoms appear, a typical mumps infection is characterized by inflammation of the parotid glands. Some infected individuals develop severe complications such as orchitis, pancreatitis, septic meningitis, and deafness. The first mumps vaccine was licensed in 1967. Soon after, the mumps vaccine was included as part of the trivalent measles, mumps, and rubella (MMR) vaccine. Currently, the MMR vaccine is given in two doses as part of a routine immunization schedule in many countries. Although widespread use of the two-dose MMR vaccine largely reduced mumps incidence among school children by the 1990s, there has been a significant increase in the number of mumps outbreaks since. Additionally, vaccine efficacy and safety remain a concern.4 Rubella, or German measles, is a mild viral infection that typically occurs in children and non-immune young adults. The prodromal illness is characterized by low-grade fever, malaise, anorexia, headaches, sore throat, and lymphadenopathy. The exanthem could be the first manifestation in children and consists of short-lived pinpoint pink macules and papules that classically begins on the face and rapidly spreads to involve the trunk and extremities. In nonpregnant individuals, rubella is generally a selflimited and benign infection. However, maternal rubella infection, especially during embryogenesis leads to the classic triad of cataracts, congenital heart defects, and sensorineural deafness; however, other defects may be seen including miscarriages, fetal death, or severe birth defects collectively known as Congenital Rubella Syndrome (CRS). Of all the manifestations, deafness in the newborn is the most common finding and could be the only defect observed. Individuals that survive the neonatal period may face severe disabilities (e.g., visual and hearing impairments) and have an increased risk for developmental disorders, including autism. Universal immunization of all susceptible individuals with rubella vaccines is the cornerstone to the prevention of rubella and, more importantly, congenital rubella syndrome. The vaccine is usually administered in combination with measles and mumps (MMR) or measles, mumps, Rubella and varicella (MMRV), with the first dose at ages 12-15 months and the second dose at ages 4-6 years.5 Immunization of all unvaccinated adolescents and adults with at least one dose of rubella vaccine is also recommended. Before the introduction of the rubella vaccine, outbreaks of rubella occurred at variable intervals of 3 to 7 years, with the highest incidence among school children. Steep declines in rubella cases occurred with the routine immunization of young children, and countries with high rates of rubella immunizations no longer see cases of rubella or CRS.6 After the introduction of the live-virus vaccine, outbreaks occurred more commonly among older adolescents and young adults.7,8 The currently used Yellow Fever Vaccine (Stamaril) is a licensed live, attenuated, lyophilized yellow fever vaccine manufactured by Sanofi Pasteur Europe, Lyon, France. A single dose of 0.5 mL contains not less than 1000 IU of yellow fever virus 17D-204 strain. The vaccine is produced in specific pathogen-free chick embryos. YF vaccine is incorporated in the Kenya Expanded Programme for Immunization (KEPI) schedule and is given at 9 months in selected endemic counties. The results of a study R01 (comparison with a prequalified MMR vaccine (Merck Sharp & Dohme or MSD) and R04 (comparison with GlaxoSmithKline’s (GSK’s) MMR vaccine) in China have sufficiently demonstrated the non-inferiority of SIBP MMR with that of licensed vaccine. However, given that these studies were carried out in an Asian population, this study could better support future use in additional jurisdictions such as Africa. The WHO Prequalification supports the specific needs of national immunization programs. Studies R05 and R06 (co-administration with varicella vaccine or with rotavirus vaccine) have also sufficiently demonstrated non-interference when co-administered with these vaccines. Since earlier studies have already assessed the immunogenicity of the vaccine in different age groups and the fact that the vaccine is in wide use in EPI of China supports not conducting any additional studies in other age groups. It is also expected that no additional studies will be required demonstrating non-inferiority between the vaccines produced from old process versus that produced by new process as the change is only in the method of cultivation of the strain virus without any change in excipients or downstream manufacturing process. The current study is designed to demonstrate non-inferiority based on the immune response of SIBP MMR vaccine when compared against an already licensed and WHO prequalified GSK MMR vaccine. In addition, the study will evaluate the interaction of co-administration of SIBP MMR vaccine with a licensed Yellow Fever (YF) vaccine in children 9-11months of age, in terms of immune responses against antigens contained in both vaccines. To study this interaction, the study is designed such that one group of children will concomitantly receive SIBP MMR and YF vaccine whereas the comparator groups will either receive SIBP MMR followed by YF vaccine six weeks later. The study is designed as an observer-blind for Group 1 vs Group 2 until Day 43 and an open label study for Group 3 from Day 1 since the number of vaccinations to be administered, the appearance of the vaccine and their containers are different in the study arms. A blood draw has been planned prior to vaccination on Day 1 and Day 43 after vaccination to measure the immune responses in the study arm as done in many prior clinical trials for licensure of the vaccine. An extended solicitation period has been included to capture solicited systemic reactions as the reaction of fever and rash are most seen in second week following vaccination. The result of this study is expected to complete the package required for applying for WHO pre- qualification for the SIBP MMR vaccine.</p>\n
      • study_title<p>\n A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.’s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9- 11 Months of Age</p>\n
      • laymans_summary<p>\n Measles is one of the most contagious diseases for humans. Measles complications such as pneumonia, diarrhea and encephalitis can occur in up to 30% of persons depending on age and predisposing conditions, such as young age, malnutrition and immunocompromising conditions. Mumps is an infectious viral disease transmitted via respiratory droplets, fomites, or personal contact. Some infected individuals develop severe complications such as orchitis, pancreatitis, septic meningitis, and deafness. Rubella is a mild viral infection that typically occurs in children and non-immune young adults. In nonpregnant individuals, rubella is generally a self-limited and benign infection. However, maternal rubella infection, especially during embryogenesis leads to the classic triad of cataracts, congenital heart defects, and sensorineural deafness; however, other defects may be seen including miscarriages, fetal death, or severe birth defects collectively known as Congenital Rubella Syndrome (CRS). Yellow fever (YF) is a mosquito borne viral disease caused by RNA virus belonging to Flavivirus genus of the Flaviviridae family. This virus is transmitted by Aedes aegypti and Haemagogous species mosquitoes, during the rainy season. This disease is endemic in the tropical and subtropical areas in South America and Africa. The current study is designed to compare the safety and immunogenicity of SIBP MMR administered alone with that of GSK MMR vaccine administered alone in the African context and to evaluate the interaction of co-administration of SIBP MMR vaccine with YF vaccine in children 9-11months of age, in terms of immune responses against antigens contained in both vaccines The results of this study is expected to complete the package required for applying for WHO pre-qualification for the SIBP MMR vaccine.</p>\n
      • short_titleSIBP-MMR-02
      • protocol_noECCT/24/05/03
      • version_no3.0
      • date_of_protocol22-03-2024
      • study_drugMeasles, Mumps and Rubella (MMR) Vaccine
      • disease_conditionMeasles, Mumps and Rubella
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name WHO Prequalified GSK MMR Vaccine
      • comparator_registeredYes
      • comparator_countriesGermany. >100 countries outside US Including European countries, Canada, Australia, pre-qualified by WHO
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressi.omollo13@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Walter Otieno
      • declaration_date105-05-2024
      • declaration_principal_investigatorDr Walter Otieno
      • declaration_date205-05-2024
      • placebo_presentNo
      • study_objectives<p>\n 1. Primary Objectives: Immunogenicity To demonstrate non-inferiority of SIBP MMR vaccine compared to GSK MMR vaccine when administered individually based on immunogenicity as measured at baseline and 42 days after vaccination.</p>\n<p>\n 2. Secondary Objectives:</p>\n<ul>\n <li>\n Safety: To assess the safety of SIBP MMR vaccine compared with the GSK MMR vaccine when administered alone in terms of immediate post-vaccination reactogenicity events, solicited adverse events, unsolicited adverse events and serious adverse events. To assess the safety of the SIBP MMR vaccine co-administered with YF vaccine compared with SIBP MMR vaccine when administered separately from YF vaccine in terms of immediate post- vaccination reactogenicity events, solicited adverse events, unsolicited adverse events, and serious adverse events.</li>\n <li>\n Immunogenicity: To evaluate the immunological interference of SIBP MMR vaccine and a licensed YF vaccine when co-administered compared to the immunogenicity when administered alone, in terms of seropositivity rate as measured at baseline and 42 days after vaccination in seronegative children, 9-11 months of age.</li>\n</ul>\n
      • principal_inclusion_criteria<p>\n 1. Healthy male and female child as established by medical history and clinical examination at enrollment.</p>\n<p>\n 2. Age: 9-11 months (inclusive) at the time of enrollment</p>\n<p>\n 3. Parent’s/legally acceptable representative’s (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site.</p>\n<p>\n 4. Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.</p>\n
      • principal_exclusion_criteria<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">1. Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery)</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">2. Acute disease of moderate to severe intensity at the time of </span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,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\')); border-bottom: 1px solid transparent;\">enrollment</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> (temporary exclusion until recovery)</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">3. Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">4. Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">5. Presence of severe malnutrition (weight-for-height z-score < -3SD median)</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">6. Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">7. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, </span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,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\')); border-bottom: 1px solid transparent;\">hematological</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> (including severe </span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,PD94bWwgdmVyc2lvbj0iMS4wIiBlbmNvZGluZz0iVVRGLTgiPz4KPHN2ZyB3aWR0aD0iNXB4IiBoZWlnaHQ9IjRweCIgdmlld0JveD0iMCAwIDUgNCIgdmVyc2lvbj0iMS4xIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHhtbG5zOnhsaW5rPSJodHRwOi8vd3d3LnczLm9yZy8xOTk5L3hsaW5rIj4KICAgIDwhLS0gR2VuZXJhdG9yOiBTa2V0Y2ggNTYuMiAoODE2NzIpIC0gaHR0cHM6Ly9za2V0Y2guY29tIC0tPgogICAgPHRpdGxlPnNwZWxsaW5nX3NxdWlnZ2xlPC90aXRsZT4KICAgIDxkZXNjPkNyZWF0ZWQgd2l0aCBTa2V0Y2guPC9kZXNjPgogICAgPGcgaWQ9IkZsYWdzIiBzdHJva2U9Im5vbmUiIHN0cm9rZS13aWR0aD0iMSIgZmlsbD0ibm9uZSIgZmlsbC1ydWxlPSJldmVub2RkIj4KICAgICAgICA8ZyB0cmFuc2Zvcm09InRyYW5zbGF0ZSgtMTAxMC4wMDAwMDAsIC0yOTYuMDAwMDAwKSIgaWQ9InNwZWxsaW5nX3NxdWlnZ2xlIj4KICAgICAgICAgICAgPGcgdHJhbnNmb3JtPSJ0cmFuc2xhdGUoMTAxMC4wMDAwMDAsIDI5Ni4wMDAwMDApIj4KICAgICAgICAgICAgICAgIDxwYXRoIGQ9Ik0wLDMgQzEuMjUsMyAxLjI1LDEgMi41LDEgQzMuNzUsMSAzLjc1LDMgNSwzIiBpZD0iUGF0aCIgc3Ryb2tlPSIjRUIwMDAwIiBzdHJva2Utd2lkdGg9IjEiPjwvcGF0aD4KICAgICAgICAgICAgICAgIDxyZWN0IGlkPSJSZWN0YW5nbGUiIHg9IjAiIHk9IjAiIHdpZHRoPSI1IiBoZWlnaHQ9IjQiPjwvcmVjdD4KICAgICAgICAgICAgPC9nPgogICAgICAgIDwvZz4KICAgIDwvZz4KPC9zdmc+\')); border-bottom: 1px solid transparent;\">anemia</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">determined</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> by medical history</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">and / or physical examination which would compromise the</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">participant’s health or is likely to result in nonconformance to the</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">protocol.</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> 8. Known or suspected impairment of immunological function based</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">on medical history and physical examination.</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> 9. Prior receipt or intent to receive measles, mumps, rubella, or </span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,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\')); border-bottom: 1px solid transparent;\">yellow</span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,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\')); border-bottom: 1px solid transparent;\">fever</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">-containing vaccine during the study vaccination and follow up</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">period up to Day 85 outside the study </span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-repeat: repeat-x; background-position: left bottom; background-image: var(--urlSpellingErrorV2, url(\'data:image/svg+xml;base64,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\')); border-bottom: 1px solid transparent;\">center</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">. </span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">10. Receipt of any vaccine (except OPV and inactivated influenza)</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">within 4 weeks of the day of study vaccination or intent to receive</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">any within 6 weeks after study vaccination. 11. Receipt of immunoglobulin therapy and / or blood products in the</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">past 9 months or planned administration during the study period</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">12. Receipt of any immune-modifying or immunosuppressant drugs</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">high dose corticosteroids (defined as ≥2 mg/kg of body weight or</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">≥20 mg/day of prednisone or equivalent for persons who weigh >10</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">kg) will be exclusionary for the study. Children on inhaled or topical</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">steroids may be </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">permitted</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> to </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">participate</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> in the study. 13. Evidence of a clinically significant major congenital anomaly or</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">genetic defect as judged by the investigator. 14. Any known or suspected bleeding disorder in the participant that</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">would pose a risk to venipuncture or intramuscular injection. 15. History of any neurologic disorders including encephalopathy, epilepsy, and other progressive neurological diseases</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">16. A known or suspected sensitivity or allergy to any components of</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">the investigational product including egg, chicken protein and the</span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> </span><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">antibiotic gentamycin. </span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<div -webkit-text-stroke-width:=\"\" background-color:=\"\" class=\"OutlineElement Ltr SCXW251702351 BCX8\" font-size:=\"\" font-style:=\"\" font-variant-caps:=\"\" font-variant-ligatures:=\"\" font-weight:=\"\" letter-spacing:=\"\" orphans:=\"\" segoe=\"\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; color: rgb(0, 0, 0); font-family: \" text-align:=\"\" text-decoration-color:=\"\" text-decoration-style:=\"\" text-decoration-thickness:=\"\" text-indent:=\"\" text-transform:=\"\" ui=\"\" white-space:=\"\" widows:=\"\" word-spacing:=\"\">\n <p class=\"Paragraph SCXW251702351 BCX8\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 10.6667px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: windowtext; text-align: left; text-indent: 0px;\">\n <span class=\"TextRun SCXW251702351 BCX8\" data-contrast=\"auto\" lang=\"EN-GB\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"><span class=\"NormalTextRun SCXW251702351 BCX8\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">17. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. Any medical condition in the parent/LAR or child which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant’s parent’s/LAR’s ability to give informed consent</span></span><span class=\"EOP SCXW251702351 BCX8\" data-ccp-props=\"{\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 12pt; line-height: 20.925px; font-family: Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, sans-serif;\"> </span></p>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n <strong>Primary Endpoints</strong></p>\n<p>\n <strong>Immunogenicity </strong></p>\n<p>\n An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine when compared GSK MMR vaccine will be measured 42 days after vaccination in seronegative children at baseline. Seropositivity rate is defined as the proportion of participants with antibody response above the cut-off point for seropositivity. The seropositivity for the antibody titers is defined as:</p>\n<ul>\n <li>\n Anti-measles immunoglobulin G (IgG) antibody concentrations by enzyme-linked immunosorbent assay (ELISA) of > 200 mIU/mL</li>\n <li>\n Anti-mumps IgG antibody concentrations by ELISA of > 100 U/mL</li>\n <li>\n Anti-rubella IgG antibody concentrations by ELISA of > 20 IU/mL</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunigenicity
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The sites have adequate staffing including investigators, study coordinators and all other roles needed for study conduct who are experienced and well trained. The facilities are well equiped including emergency facilities. There is robust infrastructure to support clinical trials.</p>\n<p>\n Kisumu County, Kenya, has a population of about 1,155,574 (Kenya National Bureau of Statistics, 2019 Census). The land area of Kisumu County totals 2085.9 km2 . The county has a shoreline on Lake Victoria, occupying northern, western and a part of the southern shores of the Winam Gulf. Several institutions that are either private or government funded provide health services in Kisumu County. There is one teaching and referral hospital, 5 County referral hospitals, 14 sub-county hospitals, 74 dispensaries and 18 health centers in the county . The Kisumu County Referral Hospital (KCRH) is a level 4 facility designed to provide preventive and curative care for patients and has the capacity for regulated clinical trials. It has a clinical laboratory including hematology, chemistry and microbiology capability. The site has a pharmacy, study drug administration area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. The hospital will serve as a clinical research site and primary storage facility for both vaccines and biological samples. Kakamega County, is located in western Kenya. It has a population of 1,867,579 and an area of 3,033.8 km2 (Kenya National Bureau of Statistics, 2019 Census). Butere is the one of largest sub- counties in Kakamega county. The population in the study area is primarily black African, and the languages spoken are Luhya (predominant ethnic group), Kiswahili and English. The Butere County Hospital (BCH) is designed to provide preventive and curative care for patients and has the capacity for regulated clinical trials. It has a clinical laboratory including hematology, chemistry and microbiology capability. The site has a pharmacy, study drug administration area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. The hospital will serve as a clinical research site. Homabay County, is located in the former Nyanza Province in Kenya. Its capital and largest town is Homa Bay. The county has a population of 1,131,950 (Kenya National Bureau of Statistics, 2019 Census) and an area of 3,154.7 km2. Lake Victoria is a major source of livelihood for Homa Bay County. The population in the study area is primarily black African, and the languages spoken are Luo (predominant ethnic group), Kiswahili and English. The Rachuonyo County Hospital (RCH) is designed as a primary care facility to provide preventive and curative care for patients. It has a clinical laboratory including hematology, and chemistry capability. The site has a pharmacy, study drug administration area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. The hospital will serve as a satellite clinical research site for the Kisumu site. The site will be used for recruitment, screening, vaccination and follow up activities. Given that VIBRI has access to a well-developed health system coupled with a strong collaborative network with the county ministries of health as well as easy accessibility of patients through the hospital networks in Kisumu County, Homabay County, Kakamega County among others, it is anticipated that the study will be able to screen and enroll participants into the study with minimal challenges. The research team will work closely with personnel working in the Ministry of Health facilities within the study area. Trained study staff will assist with study activities conducted in the field including follow up of study participants using demographic and locator information obtained at the</p>\n
      • other_details_explanation<p>\n The vaccine is already registered in the host country and the study is being conducted in Kenya to enable WHO prequalification given the dfisease burden in the country. Additionally Kenyan investigators are very experienced including experienced and established clinical trial sites.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorGSK MMR Vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyYellow Fever Vaccine
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site400-1200
      • total_participants_worldwideN/A
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyInfants aged between 9-11 months
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Walter
      • investigator1_middle_name
      • investigator1_family_nameOtieno
      • investigator1_qualificationMBChB, MMED, PhD
      • investigator1_professional_addressVictoria Biomedical Research Institute, P.O. Box 7180, Postal Code 40100, Kisumu, Kenya
      • investigator1_telephone+254714481488
      • investigator1_emailwotieno@vibriafrica.org
      • organisations_transferred_Yes
      • number_participants1200
      • notification
      • approval_date27-05-2024
      • submitted1
      • deleted0
      • deleted_date2024-05-21 18:15:59
      • deactivated0
      • date_submitted21-05-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted15-05-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer has provided approval
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-09-16 11:39:08
      • created2024-04-14 18:39:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1064
        • application_id1396
        • given_nameDr Walter
        • middle_name
        • family_nameOtieno
        • qualificationMBChB, MMED, PhD
        • professional_addressVictoria Biomedical Research Institute, P.O. Box 7180, Postal Code 40100, Kisumu, Kenya
        • telephone+254714481488
        • emailwotieno@vibriafrica.org
        • created2024-04-22 19:37:03
        • modified2024-05-21 20:52:55
      • 1(array)
        • id1065
        • application_id1396
        • given_nameDr. Diana
        • middle_name
        • family_nameOdhiambo
        • qualificationMBChB MBA MPH
        • professional_addressVictoria Biomedical Research Institute, P.O. Box 7180, Postal Code 40100, Kisumu, Kenya
        • telephone+254722243110
        • emaildodhiambo@vibriafrica.org
        • created2024-04-22 19:53:53
        • modified2024-05-21 20:52:55
    • SiteDetail(array)
      • 0(array)
        • id1698
        • application_id1396
        • county_id42
        • site_nameVictoria Biomedical Research Institute
        • physical_addressKisumu County Hospital, P.O. Box 7180, Postal Code 40100
        • contact_details+254714481488, P.O. Box 7180, Postal Code 40100
        • contact_personDr Walter Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-04-22 19:37:03
        • modified2024-05-21 20:52:55
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1699
        • application_id1396
        • county_id42
        • site_nameVictoria Biomedical Research Institute
        • physical_addressRachuonyo County Hospital Clinical Research Site, P.O. Box 7180, Postal Code 40100
        • contact_details+254714481488, P.O. Box 7180, Postal Code 40100
        • contact_personDr Walter Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-04-22 20:38:26
        • modified2024-05-21 20:52:55
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1700
        • application_id1396
        • county_id42
        • site_nameVictoria Biomedical Research Institute
        • physical_addressButere County Hospital Site, P.O. Box 7180, Postal Code 40100
        • contact_details+254722243110
        • contact_personDr. Diana Odhiambo
        • site_capacity(null)
        • misc(null)
        • created2024-04-22 20:38:26
        • modified2024-05-21 20:52:55
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id742
        • application_id1396
        • sponsorShanghai Institute of Biological Products Co
        • sponsor_typeIndustry
        • contact_personChen Zhewen
        • address 758 Guangfeng Road, Shanghai, China
        • telephone_number +86-21-67130022
        • fax_number +86-21-67130022
        • cell_number +86-21-67130022
        • email_addresschenzhewen@sinopharm.com
        • created2024-04-22 19:37:03
        • modified2024-05-21 20:52:55
  • 2(array)
    • Application(array)
      • id979
      • user_id81
      • trial_status_id6
      • abstract_of_study<p>\n In 2018, there were an estimated 228 million malaria cases worldwide, resulting in 405, 000 deaths. 93% of these occurred in the WHO African Region. In this region, Plasmodium falciparum is the most prevalent malaria parasite causing 99.7% of the estimated malaria cases. In the era of emerging possible parasite resistance to artemisinin-based drugs and wide-spread resistance among malaria vectors to insecticide classes used to treat bed nets or for indoor residual house-spraying, there is an urgent need for a highly efficacious vaccine to combat the stalling reductions in the malaria burden in Africa. Currently, RTS,S/AS01E is the most advanced malaria vaccine. However, the vaccine demonstrated moderate efficacy against clinical malaria in infants (28.3%; 95% CI 23.3-32.9) aged 6-12 weeks who received 3 vaccinations 4 weeks apart with or without a booster vaccination at 20 months. Implementation of the vaccine is currently under evaluation in Kenya, Malawi and Ghana to establish safety when distributed at scale and impact on mortality. Vaccines against malaria offer real hope for the continent, as resistance and difficulties in sustaining a complete coverage of vector control continue to pose major challenges. While RTS,S/AS01E offers some early hope, this is the only registered malaria vaccine and it is expensive. The estimated cost of RTS,S/AS01E at 7$ per dose will also be substantial if a 3-dose regime and booster(s) are considered in the KEPI schedule. The provision of an alternative, safe and efficacious vaccine candidate would increase Kenya’s options and notably related to the sustainable cost implications. One option in the development pipeline is R21/MM. Preliminary data suggest R21/MM is safe, immunogenic and prevents disease in African infants. R21 was designed to have a higher ratio of malaria antigen (i.e. circumsporozoite protein (CS)) to hepatitis B surface antigen. This allows immunogenicity to be sustained with lower doses than with RTS,S/AS01E, but does not translate into higher levels of immunogenicity than RTS,S/AS01E when judged by antibody concentrations. However, it appears that the antibody is of improved quality, since protective efficacy in both mouse and human challenge studies is higher than that observed with RTS, S/AS01E. Furthermore, the manufacture process for R21 is improved and likely to be less costly than RTS,S/AS01E. Overall, R21/MM has been shown to be safe and well tolerated across the UK and Africa (Kenya and Burkina Faso) in phase I and II trials. We will conduct a phase III randomized control trial to evaluate the efficacy of R21/MM vaccine in children (aged 5-17 months at enrolment) against clinical malaria. This is a multicentre trial with sites in Bougouni; Mali, Nanoro; Burkina Faso, Dande; Burkina Faso, Bagamoyo; Tanzania as well as Kilifi; Kenya. Each participant will be screened to ensure they are in good health based on clinical assessment and laboratory results. Each participant will have 10 clinic visits and additional safety assessments in the week following vaccination for the safety cohort. Of approximately 600 participants to be enrolled in Kilifi, 50% will be randomised to the safety cohort. Participants will receive three vaccinations at day 0, 28, and 56 and a booster dose at 12 months post third vaccination. For the safety cohort; 1) Following each vaccination, participants will be assessed for solicited and unsolicited adverse events either at home or on the phone, 2) Blood will be taken during the clinic visits for safety and/or immunological analysis. </p>\n
      • study_title<p>\n A Phase III randomized, controlled, multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria.</p>\n
      • laymans_summary<p>\n What is the problem/background?</p>\n<p>\n Malaria remains one of the leading causes of infectious disease and deaths worldwide mostly affecting children and pregnant women in sub-Saharan Africa. While globally, the number of new cases of malaria per year decreased between 2010 and 2018, the rate of change slowed from 2014 to 2018. There are several threats to controlling malaria; drug and insecticide resistance, the absence of a licensed vaccine in use and currently the COVID-19 pandemic. Mosquirix™ (RTS, S/AS01E) remains under evaluation in Africa (including studies ongoing in Western Kenya). RTS,S/AS01E is likely to be expensive due to the manufacture process, and even if the current trials in Western Kenya confirm that RTS,S is safe and efficacious when delivered at scale, sustaining funding for ongoing vaccination will be a challenge. R21/Matrix-M (R21/MM) is a candidate malaria vaccine and biologically similar to RTS,S/AS01E. R21/MM vaccine has been found to be safe and well tolerated in children and infants (n=470) when evaluated using 3 vaccinations 4 weeks apart in Burkina Faso (Nanoro-Phase IIb trial, NCT03896724) and Kenya (Kilifi-Phase Ib trial, NCT03580824). The vaccine is manufactured by the Serum Institute of India (SII) and if found to be efficacious will likely be a cost-effective alternative to RTS,S/AS01E given the good immune response seen in these studies. Since R21/MM has been found to be safe, tolerable and elicits good immune responses comparable to the RTS,S/AS01E vaccine, it is important that its efficacy is assessed to provide evidence for further clinical development and licensure with phase III trials in Africa. The option of a second licensed malaria vaccine, likely at lower price than RTS,S/AS01E and higher efficacy, would be beneficial for Kenya.</p>\n<p>\n What question are we trying to answer?</p>\n<p>\n We plan to evaluate if R21/MM, protects infants enrolled at 5-17 months of age from malaria and is safe and well tolerated. Infants will receive a three-dose vaccination course at day 0, 28 and 56 followed by a booster dose at 1 year post the third vaccination and will be followed up at 12 and 24 months following the 3 primary vaccinations.</p>\n<p>\n Where is the study taking place, how many people does it involve and how are they selected?</p>\n<p>\n The study will take place at the KEMRI Centre for Geographic Medicine Research, Coast (KEMRICGMRC). We will recruit approximately 600 healthy infants from the Kilifi population surveillance platform, the Kilifi Health and Demographic Surveillance System (KHDSS), and they should be 5-17 months at enrolment. Approximately 400 of the infants will receive the R21/MM vaccine whilst approximately 200 will receive the control rabies vaccine. Participants will be identified based on their date of birth and locator information available through the KHDSS. The decision on which vaccine they will receive will be based on chance with 2:1 participants receiving the R21/MM vaccine to ensure the results of the study can be reasonably interpreted. We will screen potential participants until we identify the required number of healthy participants. These children will be followed up for 2 years and malaria detected if children present to the KEMRI-CGMRC out-patient facilities at Junju, Pingilikani and Chasimba and the Kilifi County Hospital.</p>\n<p>\n What does the study involve for those who are in it?</p>\n<p>\n Children, whose parents/guardians provide consent and their children pass screening assessments will be enrolled into the study. Blood samples will be taken at up to 7 clinic visits (safety cohort) and additionally 3 finger prick tests to check for evidence of malaria on the days of vaccination in the event of fever or history of fever. Screening will involve a series of blood tests and clinical assessment to check for good health. For individuals who are selected for participation, blood will be drawn at different timepoints as outlined in the schedule of procedures (Table 2) and the amount of blood collected throughout the study will be approximately 30-60 mls depending on the child’s weight and within the limits regarded as appropriate by the World Health Organization (WHO). Repeat blood samples may be taken to verify abnormal results or if clinically indicated. Medical history will also be obtained and a clinical assessment performed to exclude any major health conditions. Those that pass screening will be enrolled in the trial and if a clinically significant condition is identified participants will be counselled as appropriate then referred to a government facility for further management. Once the participants are successfully screened, they will be invited for the first vaccination (Day 0). Following vaccination, participants will be observed for at least 30 minutes to check for any reactions. There will be a total of 10 clinic visits; 6 clinic visits, 4 vaccinations visits and up to 10 telephone calls to document any medical events post vaccination. In the 6 days following vaccination information will be gathered on any side effects to vaccination either over the phone or in person. The three vaccinations will occur on day 0, 28 and 56 and a booster vaccination one year after the third vaccination. The study duration for each participant will be 2 years.</p>\n<p>\n What are the benefits and risks/costs of the study for those involved?</p>\n<p>\n Studies in Kenya and Burkina Faso have shown that the vaccine is safe, tolerable and elicits good immune responses in children and infants. Participants may benefit from receipt of the vaccine given the promising efficacy data (up to 77% protected from disease) seen from the previous trial in 450 children in Burkina Faso. It remains to be demonstrated in large scale trials if the vaccine effectively prevents malarial disease and its complications. Participants will also have close oversight and treatment support from the study team although this will primarily be for risk monitoring. There will also be wider benefit in the field of malaria vaccine research in building on data available on safety, efficacy and immune responses to R21/MM which will help with the WHO’s aim to identify a malaria vaccine with high protection rates. Although the administration schedule of the rabies vaccine being used has been evaluated in clinical trials it is currently not standard practice, therefore for all children we will recommend that should they have exposure to high risk bite during the trial they get full post-exposure prophylaxis. There are also minor risks of bruising and infection associated with venepuncture and vaccination but these are minimised by appropriate training of study staff and use of sterile equipment. Participants will not bear any costs as a result of participation in this trial. Participants will also be compensated for transport costs based on distance travelled according to rates for public transport and compensated for out of pocket expenses (350 KSH). These costs will vary but may be up to approximately 2000/- per visit when catering for refreshments and additional transport requirements (spouse, siblings, impartial witness etc.).</p>\n<div>\n  </div>\n<div>\n How will the study benefit society?</div>\n<div>\n  This study will build on efficacy and immune response data of R21/Matrix M from previous phase 1 and 2 vaccine trials in Africa and will inform further clinical development of this vaccine. There is reason to believe this is a promising candidate vaccine given that a smaller dose is required to illicit a similar vaccine response to RTS,S/AS01E, manufacture is cheaper, and the data thus far on the vaccine and adjuvant Matrix-M demonstrates they are safe. </div>\n<div>\n  </div>\n<div>\n When does the study start and finish? </div>\n<div>\n The study will start upon receipt of ethical clearance; conduct of the trial including data collection, analysis and final write up will take up to 3.5 years.</div>\n
      • short_titleVAC078
      • protocol_noECCT/21/02/03
      • version_no2.0
      • date_of_protocol05-01-2021
      • study_drugR21/Matrix-M vaccine
      • disease_conditionMALARIA
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameAbhayrab
      • comparator_registeredYes
      • comparator_countriesRegistered in Kenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Mainga Hamaluba
      • declaration_date118-02-2021
      • declaration_principal_investigatorDr. Mainga Hamaluba
      • declaration_date218-02-2021
      • placebo_presentNo
      • study_objectives<p>\n Primary objectives:</p>\n<div>\n Efficacy:</div>\n<div>\n To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-17 month old children living in a malaria endemic area, 12 months after completion of the primary course (standard vaccination regime).</div>\n<div>\n To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-48 month old children living in a malaria endemic area, 12 months after completion of the primary course (seasonal vaccination regime).</div>\n<div>\n  </div>\n<div>\n Safety:</div>\n<div>\n To assess the safety and reactogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, in the month following each vaccination, and 12 months after completion of the primary course.</div>\n<div>\n  </div>\n<div>\n Secondary objectives</div>\n<div>\n <div>\n Protective efficacy</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by P. falciparum, in 5-17 month old children living in a malaria endemic area, 12 months after administration of a booster vaccination (standard vaccination regime).</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by P. falciparum, in 5-48 month old children living in a malaria endemic area, 12 months after administration of a booster vaccination (seasonal vaccination regime).</div>\n <div>\n  </div>\n <div>\n Efficacy against asymptomatic P. falciparum infection</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against asymptomatic P. falciparum infection employing either vaccination regime, in children living in a malaria endemic area, 12 months after completion of the primary course.</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against asymptomatic P. falciparum infection employing either vaccination regime, in children living in a malaria endemic area, 12 months after administration of a booster vaccination.</div>\n <div>\n  </div>\n <div>\n Efficacy against severe malaria disease</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against severe malaria disease employing either vaccination regime, in children living in a malaria endemic area, 12 months after completion of the primary course.</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M against severe malaria disease employing either vaccination regime, in children living in a malaria endemic area, 12 months after administration of a booster vaccinattion.</div>\n <div>\n  </div>\n <div>\n Efficacy according to different transmission settings</div>\n <div>\n To describe the protective efficacy of R21/Matrix-M given in the primary course, in both vaccination regimes, and with an additional booster vaccination, against clinical malaria caused by P. falciparum in different transmission settings.</div>\n <div>\n  </div>\n <div>\n <div>\n Efficacy against incident severe anaemia</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes, against incident severe anaemia after the primary course and 12 months after the booster vaccination.</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes in preventing the need for blood transfusiion</div>\n <div>\n  </div>\n <div>\n Efficacy against malaria hospitalisation</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes, against malaria hospitalisation after the primary course and 12 months after the booster vaccination.</div>\n <div>\n  </div>\n <div>\n Safety</div>\n <div>\n To assess the safety and reactogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, in the month following booster vaccination, and 12 months after administration of booster vaccination.</div>\n <div>\n  </div>\n <div>\n Immunogenicity</div>\n <div>\n To assess the humoral immunogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, 28 days and 12 months after completion of the primary course.</div>\n <div>\n To assess the humoral immunogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, 28 days and 12 months after administration of booster vaccination.</div>\n <div>\n  </div>\n <div>\n <div>\n Exploratory objectives:</div>\n <div>\n  </div>\n <div>\n Efficacy against prevalence of severe anaemia</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes, against prevalence of severe anaemia 12 months after the primary course and 12 months after the booster vaccination.</div>\n <div>\n  </div>\n <div>\n Efficacy against other serious illnesses</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes, against other serious illnesses (pneumonia, sepsis, all-case hospitalisation*) 12 months after the primary course and 12 months after the booster vaccination.</div>\n <div>\n * Excluding hospitalisation as a result of trauma or elective surgery</div>\n <div>\n  </div>\n <div>\n Efficacy against fatal malaria and all-cause mortality</div>\n <div>\n To assess the protective efficacy of R21/Matrix-M, in both vaccination regimes, against fatal malaria and all-cause mortality** 12 months after the primary course and 12 months after the booster vaccination.</div>\n <div>\n ** Excluding mortality as a result of trauma or elective surgery</div>\n <div>\n  </div>\n <div>\n Gender-specific efficacy</div>\n <div>\n To assess the vaccine efficacy of R21/Matrix-M, in both vaccination regimes, with or without a booster vaccination, according to gender.</div>\n <div>\n  </div>\n <div>\n <div>\n Effect of vaccine on growth</div>\n <div>\n To assess the effect of R21/Matrix-M, in both vaccination regime, with or without a booster vaccination, on growth of children.</div>\n <div>\n  </div>\n <div>\n Safety and immunogenicity in specific groups</div>\n <div>\n To assess safety and immunogenicity of R21/Matrix-M, in both vaccination regimes, with or without a booster vaccination, of children with low weight and very low weight according to z-score.</div>\n <div>\n To assess safety and immunogenicity of R21/Matrix-M, in both vaccination regimes, with or without a booster vaccination, in HIV-infected child</div>\n <div>\n  </div>\n <div>\n Immunogenicity</div>\n <div>\n To evaluate immunogenicity, magnitude, quality and functionality of induced antibodies to the circumsporozoite protein, antibodies to HBsAg and other exploratory immunological end points in all vaccination groups.</div>\n <div>\n  </div>\n <div>\n Genotypes</div>\n <div>\n To evaluate any potential impact of parasite genetic variation sequence in the P. falciparum circumsporozoite protein (CSP). Other relevant Plasmodium gene analysis may be undertaken to define local parasite populations, define the strain of parasites against which efficacy is being measured, and search for any evidence of differential efficacy of the R21/MM vaccine against different parasite genotypes. In studies of participant human DNA samples, genotyping may be undertaken to evaluate impact of host genetics on risk of malaria disease, the magnitude and quality of immune responses to vaccination and vaccine efficacy.</div>\n </div>\n </div>\n </div>\n</div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<div>\n Inclusion criteria</div>\n<div>\n All participants must satisfy the following criteria at study entry:</div>\n<div>\n For standard vaccination regime, the child is 5-17 months of age at the time of first vaccination.</div>\n<div>\n For seasonal vaccination regime, the child is 5-48 months of age at the time of first vaccination.</div>\n<div>\n Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.</div>\n<div>\n The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.</div>\n<div>\n The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial.</div>\n
      • principal_exclusion_criteria<div>\n  Exclusion criteria for enrolment:</div>\n<div>\n  </div>\n<div>\n The following criteria should be checked at the time of study entry. If any apply, the participant must not be included:</div>\n<div>\n The child has previously received a malaria vaccine.</div>\n<div>\n The child is enrolled in another malaria intervention trial.</div>\n<div>\n The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria or control vaccine.</div>\n<div>\n The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.</div>\n<div>\n The child has major congenital defects.</div>\n<div>\n The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.</div>\n<div>\n The child has had a blood transfusion within one month of enrolment.</div>\n<div>\n The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.</div>\n<div>\n The child has malnutrition requiring hospital admission.</div>\n<div>\n The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.</div>\n<div>\n Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.</div>\n<div>\n The child has received an investigational drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.</div>\n<div>\n The child is currently participating in another clinical trial if likely to affect data interpretation of this trial</div>\n<div>\n The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.</div>\n<div>\n  </div>\n<div>\n <div>\n Exclusion criteria during the study</div>\n <div>\n The following criteria should be checked during the study, prior to each vaccination:</div>\n <div>\n Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n <span style=\"font-size:14px;\">Primary efficacy endpoint: efficacy against clinical malaria disease over one year for each of the two vaccination regimes as well as in the trial population as a whole.</span></p>\n<p>\n Primary Outcome Measures:</p>\n<ol font-size:=\"\" helvetica=\"\" margin-bottom:=\"\" margin-top:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; font-family: \">\n <li style=\"box-sizing: border-box; font-size: 15px; line-height: 1.6; margin-top: 0.7ex;\">\n Efficacy To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-48 month old children living in a malaria endemic area, 12 months after completion of the primary course. [ Time Frame: 2 years ]\n <div class=\"tr-indent2\" style=\"box-sizing: border-box; line-height: 1.6; clear: both; margin-left: 1em; margin-top: 1ex;\">\n <p style=\"box-sizing: border-box; line-height: 1.6; margin: 0ex 0px 1ex;\">\n Assessment for all efficacy outcomes will begin from 14 days after primary course of vaccination to specified time point.</p>\n <p style=\"box-sizing: border-box; line-height: 1.6; margin: 0ex 0px 1ex;\">\n Clinical malaria Primary case definition: Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia > 5000 parasites/µL Secondary case definitions: Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia > 0 parasites/µL Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia > 2500 parasites/µL Tertiary case definitions: Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia > 500 parasites/µL Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia > 20,000 parasites/µL or RDT positive.</p>\n <p style=\"box-sizing: border-box; line-height: 1.6; margin: 0ex 0px 1ex;\">\n  </p>\n </div>\n </li>\n <li style=\"box-sizing: border-box; font-size: 15px; line-height: 1.6; margin-top: 0.7ex;\">\n Safety • To assess the safety and reactogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, in the month following each vaccination, and 12 months after completion of the primary course. [ Time Frame: 2 years ]\n <div class=\"tr-indent2\" style=\"box-sizing: border-box; line-height: 1.6; clear: both; margin-left: 1em; margin-top: 1ex;\">\n <p style=\"box-sizing: border-box; line-height: 1.6; margin: 0ex 0px 1ex;\">\n Solicited adverse events</p>\n <ul style=\"box-sizing: border-box; margin-top: 1ex; margin-left: 0px; padding-left: 24px; margin-bottom: 1ex;\">\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination.</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination. Unsolicited adverse events</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Occurrence of unsolicited adverse events for 28 days following the vaccination. Laboratory adverse events</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Change from baseline for safety laboratory measures thought to be clinically significant. Serious adverse events</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Occurrence of serious adverse events for the whole study duration.</li>\n </ul>\n </div>\n </li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site has long standing experience in conducting clinical research with currently over 200 studies in clinical research including phase I - IV trials, human infection studies, cohort studies in children and surveillance of paediatric and maternity admissions at delivery. KEMRI-CGMRC has close to 1000 employees and about a third of them are scientists. All clinical trial staff are trained in acute resuscitation and in the event of emergencies provisions are in place for resuscitation and ambulance transfer to either the KEMRI-HDU ward or Intensive Care at the Aga Khan Hospital, Mombasa. KEMRI HDU is fully staffed with Paediatricians and adult physicians (up to 10 staff contribute to the on-call rota), nurses including a nurse manager, 6 clinical officers, 2 pharmacists, 4 pharmaceutical technologists and 5 pharmacy dispensing clerks as well as study specific staff. If participants require non-critical care they will be admitted to the general wards where KEMRI staff will also oversee their care. The following staff will be supporting this trial:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Medical officer-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Clinical officer - 3</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Nurses -3</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Fieldworkers - 15</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Study Coordinator -1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Pharmacisit-2</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Data Manager-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Data Clerk-3</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n All staff are trained in basic life support and resuscitation facilities are available</p>\n
      • other_details_explanation<p>\n The sponsor of the trial is the University of Oxford. Since  this is on efficacy and effectiveness in a malaria endemic setting, it could not be conducted in the United Kingdom.</p>\n
      • other_details_regulatory_notapproved<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">A joint submission has been initiated by the Sponsor through AVAREF.</span></p>\n
      • other_details_regulatory_approved<p>\n <span style=\"color: rgb(51, 51, 51); font-family: \">A joint submission has been initiated by the Sponsor through AVAREF. This will cater for Burkina Faso, Kenya, Mali and Tanzania.</span></p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationTwo and a half years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRabivax-S Rabies vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Wellcome Trust Research Programme
      • single_site_physical_addressHospital Grounds, Off Bofa Road, Kilifi, Kenya
      • single_site_contact_personMainga Hamaluba
      • single_site_telephone+254709983946
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listKenya, Tanzania, Mali and Burkina Faso
      • data_monitoring_committeeYes
      • total_enrolment_per_site600
      • total_participants_worldwide4800
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyIn the standard vaccination regimen, we will enroll children aged 5-17 months old and 5-48 months old in the seasonal vaccination regime.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf. Adrian Vivian Sinton
      • investigator1_middle_name
      • investigator1_family_nameHill
      • investigator1_qualificationProfessor of Human Genetics at the University of Oxford
      • investigator1_professional_addressJenner Institute, University of Oxford. ORCRB, Roosevelt Drive OX3 7DQ
      • investigator1_telephone+ 44 7881826377
      • investigator1_emailadrian.hill@ndm.ox.ac.uk
      • organisations_transferred_Yes
      • number_participants600
      • notification
      • approval_date02-04-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-06-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-10-09 13:29:21
      • created2021-02-16 16:28:13
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id619
        • application_id979
        • given_nameMainga Patience Mayeso
        • middle_name
        • family_nameHamaluba
        • qualificationMBChB MRCPCH MD
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone(+254) 795 3204 22
        • emailMHamaluba@kemri-wellcome.org
        • created2021-02-16 16:38:00
        • modified2021-06-11 17:40:38
      • 1(array)
        • id620
        • application_id979
        • given_nameJean Bosco
        • middle_name
        • family_nameOuedraogo
        • qualificationMD Parasitologist and Medical Researcher
        • professional_addressInstitut des Sciences et Techniques (INSTech), 540 Avenue de Sya, 01 BP 2779, Bobo-Dioulasso, Burkina Faso
        • telephone(226) 20981880
        • emailjbouedraogo.irssbobo@fasonet.bf
        • created2021-02-16 16:45:58
        • modified2021-06-11 17:40:38
      • 2(array)
        • id621
        • application_id979
        • given_nameHalidou
        • middle_name
        • family_nameTinto
        • qualificationProfessor of Parasitology, Pharm D, PhD
        • professional_addressUnité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), 42 Avenue Kumda-Yonre, 11 BP218 Ouagadougou CMS 11 Burkina Faso.
        • telephone+226 70346354
        • emailtintoh@fasonet.bf
        • created2021-02-16 16:47:23
        • modified2021-06-11 17:40:38
      • 3(array)
        • id622
        • application_id979
        • given_nameAlassane
        • middle_name
        • family_nameDicko
        • qualificationProfessor Department of Research Institute of Health Science
        • professional_addressMalaria Research & Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Dentistry, University of Sciences Techniques and Technologies of Bamako, P.O. Box 1805 Bamako, Mali
        • telephone+223 2022 8109
        • emailadicko@icermali.org
        • created2021-02-16 16:48:21
        • modified2021-06-11 17:40:38
      • 4(array)
        • id623
        • application_id979
        • given_nameAlly
        • middle_name
        • family_nameOlotu
        • qualificationclinical epidemiology and vaccinology
        • professional_addressIfakara Health Institute, Bagamoyo Research and Training centre, PO Box 74, Bagamoyo, Tanzania
        • telephone+255 718 927 104
        • emailndaskoiolotu@gmail.com
        • created2021-02-16 16:49:37
        • modified2021-06-11 17:40:38
    • SiteDetail(array)
      • 0(array)
        • id857
        • application_id979
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-02-16 16:38:00
        • modified2021-06-11 17:40:38
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id479
        • application_id979
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personAdrian Hill (Chief Invetigator)
        • addressUniversity Offices, Wellington Square, Oxford, OX1 2JD, UK
        • telephone_number+44 1865 270000
        • fax_number
        • cell_number+44 1865 270000
        • email_addressadrian.hill@ndm.ox.ac.uk
        • created2021-02-16 16:38:00
        • modified2021-06-11 17:40:38
  • 3(array)
    • Application(array)
      • id1415
      • user_id693
      • trial_status_id6
      • abstract_of_study<div>\n <strong>BACKGROUND</strong></div>\n<div>\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div>\n  </div>\n<div>\n <strong>STUDY RATIONALE</strong></div>\n<div>\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div>\n  </div>\n<div>\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div>\n Primary Objective:</div>\n<div>\n To evaluate the long-term safety of astegolimab</div>\n<div>\n Corresponding Endpoint:</div>\n<div>\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div>\n  </div>\n<div>\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div>\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the Mtwapa site targeting minimum of five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div>\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p>\n A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</p>\n
      • laymans_summary<div>\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div>\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div>\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div>\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div>\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/06/02
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameAstegolimab (RO7187807)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantKarabo Tsoku
      • declaration_date113-06-2024
      • declaration_principal_investigatorProf Videlis Nduba
      • declaration_date213-06-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective</strong></p>\n<ul>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<p>\n <strong>Exploratory Objectives</strong></p>\n<ul>\n <li>\n To evaluate the efficacy of astegolimab</li>\n <li>\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n <li>\n To characterize the PK profile of astegolimab</li>\n <li>\n To evaluate the immune response to astegolimab</li>\n <li>\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul>\n <li>\n Signed Informed Consent Form.</li>\n <li>\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li>\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li>\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause),and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li>\n Any permanent discontinuation of study drug in parent study</li>\n <li>\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment</li>\n <li>\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.</li>\n <li>\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</li>\n <li>\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study</li>\n <li>\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry</li>\n <li>\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study</li>\n <li>\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab</li>\n <li>\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study</li>\n <li>\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</li>\n <li>\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</li>\n <li>\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</li>\n</ul>\n
      • primary_end_points<div>\n <strong>Primary Objective Endpoints</strong></div>\n<div>\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted at the Center for Research in Tropical Medicine and Community Development, Clinical Research Unit (CRU) which is housed within Mary Help of the Sick Mission Hospital, Thika. The clinical research unit has been designed and equipped for the conduct of Phase 3 Clinical trials. The facility comprises of; phlebotomy and triage suites, examination rooms, clinical research laboratory department with calibrated equipments, clinical research pharmacy department with IP storage area that is temperature controlled, Theatre, male wards, female wards, pediatric ward, research medical records facility and storage space and administrative offices.</p>\n<p>\n The CRU is well-staffed by trained personnel with expertise in the following research related tasks:</p>\n<ul>\n <li>\n Clinical Research Nurses: Obtain Informed consents, Make CRF entries/resolve queries; Collect medical information; Vital signs; Collect adverse events; Administer IP; Participant recruitment and retention; Safety contact info portal receipt.</li>\n <li>\n Pharmacist and Pharmacy Technologist: Investigational Drug Services: Manage IP receipt/return; Prepare and dispense IP; IXRS access.</li>\n <li>\n Regulatory Coordinator: Manage submissions to ethics and regulatory authorities. Maintain essential documents and ensure compliance.</li>\n <li>\n Contracts and Budgets: Maintain legal and financial documents; Ensure appropriate invoicing to the Sponsor; Ensure appropriate processes for research covered procedures versus patients’ standard of care.</li>\n <li>\n Data Management: Data entry and management; Make CRF entries/resolve queries; maintain the patients’ research documents, Epip access.</li>\n <li>\n Clinical research coordinator: Oversight of CRTMCD’s Clinical Research Unit’s studies and staff; support all research staff with their tasks; Reporting AEs/SAEs; ISERC communication; Study logistics; EDC access; Epip access; Gobalto access; LabCorp lab kit shipment receipt; Lab corp portal access.</li>\n <li>\n Laboratory Investigator: Laboratory sample collection; Data collection and storage; Lab corp portal access.</li>\n <li>\n Investigators/Clinical research doctors: Obtain Informed Consent; Assess eligibility; Make CRF entries/resolve Queries; Medical decisions/review; Collect medical information; Vital signs; Assess Ordinal Scale; Collect/Assess Adverse Events; Administer IP; Conduct Physical Exam; Collect Lab Samples; Maintain Essential Documents; IP processes</li>\n</ul>\n<p>\n Mary Help of the Sick Mission Hospital has a Renal Unit. The facility is designed to provide an integrated, patient-centered service across the care cycle from diagnosis through treatment, survivorship and palliative care. The Renal unit also offers streamlined, care by multidisciplinary team of specialists. This coordinated approach allows for all-inclusive care to patients that require dialysis and their families as a one stop service.</p>\n<p>\n All patients treated at Mary Help of the Sick Mission Hospital have access to psychosocial and support counselling as well as palliative care support as part of Mary Help of the Sick Mission Hospital best practice. This is not limited to non-study patients and thus is available to study patients as well. The Mary Help of the sick Mission Hospital approach to care is guided by core principles of Quality, Access, Impact and Relevance and its healthcare practices are of the highest quality and this will be available to the study participants as well.</p>\n
      • other_details_explanation<p>\n Switzerland is the host country and we already received approval in Switzerland. CEC and RA approvals were received on 17-Sep-2024</p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 21px;\">\n <p>\n <strong>I</strong><strong>NDIA                                                                                DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 30-Apr-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 18px;\">\n <p>\n <strong>P</strong><strong>HILIPPINES</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 18-Apr-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n To be submitted</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 16-May-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>K</strong><strong>ENYA</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 13-Jun-2024 (first site)</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n AUSTRIA</td>\n <td style=\"width: 141px; height: 18px;\">\n 25Jun2024</td>\n <td style=\"width: 161px; height: 18px;\">\n Pending expected by 24-Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 37px;\">\n <p>\n <strong>List of Competent Authorities inside the EU/EEA to which the Application has been Approved</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n <strong>Member State </strong></p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"width: 141px; height: 107px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width: 161px; height: 107px;\">\n <p>\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n GREECE, HUNGARY, ITALY, LATVIA</p>\n </td>\n <td style=\"width: 141px; height: 107px;\">\n <p>\n 25-Jun-2024</p>\n </td>\n <td style=\"width: 161px; height: 107px;\">\n <p>\n  </p>\n <p>\n GREECE – Approved, 18-Sep2024</p>\n <p>\n HUNGARY - Approved, 03-Sep2024</p>\n <p>\n ITALY - Approved, 16-Sep2024</p>\n <p>\n LATVIA - Approved, 17-Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 36px;\">\n <p>\n 25-May-2023</p>\n </td>\n <td style=\"width: 161px; height: 36px;\">\n <p>\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 22-Jun-2023</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n 02-Jun-2023</p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 19px;\">\n <p>\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 19px;\">\n  </td>\n <td style=\"width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n 18-Oct-2023</p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 19px;\">\n <p>\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"width: 141px; height: 19px;\">\n  </td>\n <td style=\"width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n 24-Aug-2023</p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 21px;\">\n <p>\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 21px;\">\n  </td>\n <td style=\"width: 161px; height: 21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n 28-Jul-2023 </p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 36px;\">\n <p>\n 24-May-2023</p>\n </td>\n <td style=\"width: 161px; height: 36px;\">\n <p>\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 36px;\">\n <p>\n 14-Jun-2023</p>\n </td>\n <td style=\"width: 161px; height: 36px;\">\n <p>\n Approved, 7-Jul2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width: 141px; height: 37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width: 161px; height: 37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 36px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width: 161px; height: 36px;\">\n <p>\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 36px;\">\n <p>\n 9-Jun-2023</p>\n </td>\n <td style=\"width: 161px; height: 36px;\">\n <p>\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n  </td>\n <td style=\"width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 13-Feb-2023</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 18px;\">\n <p>\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 29-Mar-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 18px;\">\n <p>\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 20-Mar-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 29-Jul-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 21-May-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n 25-Jun2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationStudy participation for each individual is expected is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states34
      • number_of_sitesApproximately 5 sites
      • multi_country_listBelgium, Bulgaria, Czech Republic, Denmark, France, Germany, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom, Argentina, Australia, Chile, Hong Kong, Mexico, Canada, Israel, New Zealand, Peru, South Africa, South Korea, United States of America, Switzerland, Taiwan, Thailand, Turkey, India, China, Brazil, Kenya, Vietnam, Phillipine
      • data_monitoring_committeeYes
      • total_enrolment_per_siteApproximately 3 participants at this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date25-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-06-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted13-06-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-18 17:59:41
      • created2024-05-24 13:26:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1073
        • application_id1415
        • given_nameJesse
        • middle_name
        • family_nameGitaka
        • qualificationMedical Doctor
        • professional_addressP.O. Box 6387 Thika, Kenya
        • telephone+254722425613
        • emailjgitaka@mku.ac.ke
        • created2024-05-24 13:49:34
        • modified2024-10-31 08:04:38
    • SiteDetail(array)
      • 0(array)
        • id1713
        • application_id1415
        • county_id47
        • site_nameCenter for Research In Tropical Medicine and Community Development
        • physical_addressP.O. Box 6387, Thika, Kenya
        • contact_details+254722425613
        • contact_personDr Jesse Gitaka
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 13:49:34
        • modified2024-10-31 08:04:38
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1714
        • application_id1415
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 14:41:48
        • modified2024-10-31 08:04:38
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 2(array)
        • id1715
        • application_id1415
        • county_id3
        • site_nameKEMRI-Mtwapa Clinical Annex
        • physical_addressP.O. Box 428-80108, Mtwapa
        • contact_details+254722523370
        • contact_personDr Mary Matilu
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 14:42:38
        • modified2024-10-31 08:04:38
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 3(array)
        • id1716
        • application_id1415
        • county_id47
        • site_nameUniversity of Nairobi Clinical Research Centre
        • physical_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • contact_details+254 707028067
        • contact_personDr Teresa Kinyari
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 14:43:13
        • modified2024-10-31 08:04:38
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1717
        • application_id1415
        • county_id47
        • site_nameKEMRI-CRDR Clinical Research Annex
        • physical_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • contact_details+254790484654
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 14:43:53
        • modified2024-10-31 08:04:38
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id749
        • application_id1415
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+41 6168 81111
        • fax_number
        • cell_number+416-930-1484
        • email_addressglobal.eudract@roche.com
        • created2024-05-24 13:49:34
        • modified2024-10-31 08:04:38
  • 4(array)
    • Application(array)
      • id1452
      • user_id693
      • trial_status_id6
      • abstract_of_study<div>\n <strong>BACKGROUND</strong></div>\n<div>\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div>\n  </div>\n<div>\n <strong>STUDY RATIONALE</strong></div>\n<div>\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div>\n  </div>\n<div>\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div>\n Primary Objective:</div>\n<div>\n To evaluate the long-term safety of astegolimab</div>\n<div>\n Corresponding Endpoint:</div>\n<div>\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div>\n  </div>\n<div>\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div>\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the sites targeting approximately five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div>\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p>\n A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</p>\n
      • laymans_summary<div>\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div>\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div>\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div>\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div>\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/08/03
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameAstegolimab (RO7187807)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantKarabo Tsoku
      • declaration_date113-08-2024
      • declaration_principal_investigatorProf Videlis Nduba
      • declaration_date213-08-2024
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary Objective</strong></div>\n<ul>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<div>\n <strong>Exploratory Objectives</strong></div>\n<ul>\n <li>\n To evaluate the efficacy of astegolimab</li>\n <li>\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n <li>\n To characterize the PK profile of astegolimab</li>\n <li>\n To evaluate the immune response to astegolimab</li>\n <li>\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul>\n <li>\n Signed Informed Consent Form.</li>\n <li>\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li>\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li>\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li>\n Any permanent discontinuation of study drug in parent study</li>\n <li>\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment</li>\n <li>\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.</li>\n <li>\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</li>\n <li>\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study</li>\n</ul>\n<div>\n <ul>\n <li>\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry</li>\n <li>\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study</li>\n <li>\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab</li>\n </ul>\n <div>\n <ul>\n <li>\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study</li>\n </ul>\n <div>\n <ul>\n <li>\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</li>\n </ul>\n <div>\n <ul>\n <li>\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</li>\n <li>\n <div>\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</div>\n </li>\n </ul>\n </div>\n </div>\n </div>\n</div>\n
      • primary_end_points<div>\n <strong>Primary Objective Endpoints</strong></div>\n<div>\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site has a network of health facilities and communities  that collaborate with KEMRI in clinical trials; the site reaches out to these stakeholders to refer eligible participants.</p>\n<p>\n The KEMRI-Mtwapa Clinical Research site is a fully equipped trial site. The site has a fully equipped laboratory with the ability to perform basic clinical tests including full blood count, renal and liver function tests and other chemistry tests. It has been equipped with a sponsor-provided Spirometer with ECG performance capability. Study staff have been trained on spirometry the use of the ECG component.</p>\n<p>\n The site has access to appropriate safety measures and has highly capable clinical site personnel experienced in conducting clinical trials. Site staff include the principal investigator, 4 Sub-PIs, 1 medical officer, 2 clinical officers, 1 administrator and 4 community health workers. The site is taking part in the parent 52-week placebo-controlled Phase III (GB44332) astegolimab study, a prerequisite for this  open-label extension (OLE) study. </p>\n
      • other_details_explanation<p>\n Switzerland is the host country and we already received approval in Switzerland. CEC and RA approvals were received on 17-Sep-2024</p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:21px;\">\n <p>\n <strong>I</strong><strong>NDIA                                                                                DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 30-Apr-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>P</strong><strong>HILIPPINES</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 18-Apr-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n To be submitted</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 16-May-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>K</strong><strong>ENYA</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 13-Jun-2024 (first site)</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n AUSTRIA</td>\n <td style=\"width:141px;height:18px;\">\n 25Jun2024</td>\n <td style=\"width:161px;height:18px;\">\n Pending expected by 24-Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:37px;\">\n <p>\n <strong>List of Competent Authorities inside the EU/EEA to which the Application has been Approved </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Member State </strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n GREECE, HUNGARY, ITALY, LATVIA</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 25-Jun-2024</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n  </p>\n <p>\n GREECE – Approved, 18-Sep2024</p>\n <p>\n HUNGARY - Approved, 03-Sep2024</p>\n <p>\n ITALY - Approved, 16-Sep2024</p>\n <p>\n LATVIA - Approved, 17-Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 25-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 22-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 02-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 18-Oct-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 24-Aug-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:21px;\">\n <p>\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:21px;\">\n  </td>\n <td style=\"width:161px;height:21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 28-Jul-2023 </p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 24-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 14-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 7-Jul2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 9-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 13-Feb-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 20-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Jul-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 21-May-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 25-Jun2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationStudy participation for each individual is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states39
      • number_of_sitesApproximately 5 sites
      • multi_country_listAUSTRALIA, CHINA,HONG KONG,INDIA,JAPAN, NEW ZEALAND, PHILIPPINES, SOUTH KOREA, TAIWAN, THAILAND, BRAZIL, ARGENTINA, CANADA, CHILE, MEXICO, PERU, AUSTRIA, BELGIUM, BULGARIA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, HUNGARY, ITALY, LATVIA, NETHERLANDS, POLAND, ROMANIA, SPAIN, SWEDEN, ISRAEL, KENYA, SOUTH AFRICA, SWITZERLAND, TURKEY, UNITED KINGDOM, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site 5 participants for this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date21-12-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-08-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted13-08-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonResponse to review comments satisfactory
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-19 08:35:01
      • created2024-08-06 09:58:32
      • total_sites5
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1127
        • application_id1452
        • given_nameMary Inziani
        • middle_name
        • family_nameMatilu
        • qualificationMedical Doctor
        • professional_addressKEMRI-Mtwapa Clinical Annex P.O. Box 428-80108, Mtwapa
        • telephone+254722523370
        • emailinzianimatilu@gmail.com
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
    • SiteDetail(array)
      • 0(array)
        • id1764
        • application_id1452
        • county_id3
        • site_nameKEMRI-Mtwapa Clinical Annex
        • physical_addressP.O. Box 428-80108, Mtwapa
        • contact_details+254722523370
        • contact_personDr Mary Matilu
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id1765
        • application_id1452
        • county_id47
        • site_nameCenter for Research In Tropical Medicine and Community Development
        • physical_addressP.O. Box 6387, Thika, Kenya
        • contact_details+254722425613
        • contact_personDr Jesse Gitaka
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:06:27
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1766
        • application_id1452
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 3(array)
        • id1767
        • application_id1452
        • county_id47
        • site_nameUniversity of Nairobi Clinical Research Centre
        • physical_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • contact_details+254 707028067
        • contact_personDr Teresa Kinyari
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1768
        • application_id1452
        • county_id47
        • site_nameKEMRI-CRDR Clinical Research Annex
        • physical_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • contact_details+254790484654
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id770
        • application_id1452
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+ 41 6168 81111
        • fax_number
        • cell_number+416-930-1484
        • email_addressglobal.eudract@roche.com
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
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  • Permission(empty)
  • Aro(empty)
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  • Application(empty)
  • User(empty)
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  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
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  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

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