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  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id914
      • user_id636
      • trial_status_id5
      • abstract_of_study<p style=\"direction: ltr; \">\n First in human study to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Feefteen subjects will be enrolled after screening by the participating clinical sites’ clinical team (physician and study staff) during a screening visit. Each subject will sign the ICF prior to any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr;\">\n  </p>\n
      • study_title<p dir=\"ltr\">\n <strong>The CorNeat EverPatch – A First-In-Human Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts</strong></p>\n<p>\n  </p>\n
      • laymans_summary<p style=\"direction: ltr; \">\n This is a First in human study aimed to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Each subject will sign an informed consent form prior to any study activities. Subjects will be screened by the participating clinical sites’ clinical team (physician and study staff) during a screening visit and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • short_titleCorNeat EverPatch
      • protocol_noECCT/20/08/01
      • version_no7.2
      • date_of_protocol11-06-2020
      • study_drugCorNeat EverPatch
      • disease_conditionConcealment of artificial implants and glaucoma tube shunts
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_namePermanent ophthalmic implant
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressido@corneat.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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGerry Tal
      • declaration_date103-08-2020
      • declaration_principal_investigatorLily Nyamai
      • declaration_date203-08-2020
      • placebo_presentNo
      • study_objectives<p style=\"direction: ltr; \">\n This clinical trial will assess the safety of the CorNeat EverPatch device</p>\n
      • principal_inclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Male or female</li>\n <li style=\"direction: ltr; text-align: left;\">\n Aged ≥ 18 and ≤ 80 years on screening day</li>\n <li style=\"direction: ltr; text-align: left;\">\n Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Candidates must have the ability and willingness to attend all scheduled visits and   comply with all study procedures</li>\n <li style=\"direction: ltr; text-align: left;\">\n Adequate tear film and lid function </li>\n <li style=\"direction: ltr; text-align: left;\">\n Visual acuity of light perception or better</li>\n <li style=\"direction: ltr; text-align: left;\">\n Female patients of childbearing age must agree to use a method of contraception and have negative pregnancy test at screening. An effective method of contraception must be used throughout the study.</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Current retinal detachment</li>\n <li style=\"direction: ltr; text-align: left;\">\n Active ocular or orbital infection</li>\n <li style=\"direction: ltr; text-align: left;\">\n History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of ocular or periocular malignancy</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of extensive keloid formation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or         component of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Signs of current infection, including fever and current treatment with antibiotics</li>\n <li style=\"direction: ltr; text-align: left;\">\n Severe generalized disease that results in a life expectancy shorter than a year</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Currently pregnant or breastfeeding</li>\n <li style=\"direction: ltr; text-align: left;\">\n Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Intraoperative complication that would preclude implantation of the study device.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any traumatic perforation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage</li>\n <li style=\"direction: ltr; text-align: left;\">\n Loss of scleral integrity where use of tissue or substitutes is indicated</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • primary_end_points<p style=\"direction: ltr;\">\n Primary Safety Endpoint:</p>\n<p style=\"direction: ltr;\">\n The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, and follow-up for up to 12 months will be 10% or less.</p>\n<p style=\"direction: ltr;\">\n Effectiveness Endpoints:</p>\n<p style=\"direction: ltr;\">\n Primary: Conjunctival integrity at the implantation site will be 90% or more.</p>\n<p style=\"direction: ltr;\">\n Secondary: Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients</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_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p dir=\"RTL\" style=\"direction: ltr; margin-right: 5.4pt;\">\n The proposed sites can ensure patient safety as they are centers of excellence. The centers are all well equipped to manage glaucoma cases and any complication if they occur; they all have well-equipped clinics, OR (operating room), pharmacies and lasers used in glaucoma (YAG, SLT). The PI will conduct enrollment, surgeries and follow-up in both centers. There is room for cross referral across disciplines in all centers.</p>\n<p style=\"direction: ltr;\">\n Additionally, EverPatch device replaces the use of artificial / tissue-based patches and does not require any specific change in the implantation procedure. Dr. Nyamai has successfully completed the Sponsor’s training during which the necessary information pertaining the specific protocol, the investigational product, data collection procedures and safety management was provided. This training was set to ensure that the clinical study will be conducted in accordance with the study protocol and Good Clinical Practice principles.</p>\n<p style=\"direction: ltr;\">\n <u>Description of Study Sites in Kenya:</u></p>\n<ol>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>Lions SightFirst Hospital</strong> -  is the largest eye hospital in Kenya. It is well equipped with subspecialty clinics, operating room (OR), diagnostic equipment (OCT and visual fields), pharmacies and lasers used in glaucoma (Argon, YAG). The glaucoma patients at the Lions SightFirst hospital are currently followed up by general ophthalmologists and clinical officers.  These ophthalmologists get referrals from outreach activities and other subspecialty clinics (cornea and retina). The clinic has an average of 20- 30 glaucoma patients visiting per week with 7-10 glaucoma surgeries performed per week. The PI will carry out a glaucoma clinic on two clinic days and one operating day for purposes of the study.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kenyatta National Hospital</strong> – is the oldest and largest hospital in the country. The PI also runs a general ophthalmology clinic in the KNH COC, with an average of 5 patients a month with a diagnosis of glaucoma. As the clinic in COC is relatively new and first line treatment for glaucoma is eye drops, only about 1 patient a month or less requires an Ahmed Glaucoma Valve (AGV) insertion. Ophthalmologists from the specialist clinics from the general eye clinic in the hospital will also be engaged by referring cases for AGV insertion.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kwale Eye institute</strong> - is a well-equipped center with clinics, OR, diagnostic equipment (OCT and visual fields) pharmacy, wet-lab and lasers used in glaucoma (SLT, YAG & Argon). The Kwale Eye Center has about 20 glaucoma patients per week seen at the general ophthalmology clinic. Glaucoma surgeries performed are about 3 per week. The PI will carry out clinic and OR for purposes of the study as deemed necessary.</li>\n</ol>\n<p style=\"direction: ltr;\">\n The PI assists with outreach activities at the Kwale Eye Center and was trained in cataract surgery and general ophthalmology in this center during her elective term as a resident in ophthalmology under the mentorship of Dr. Helen Roberts, a general ophthalmologist  and medical director of the hospital</p>\n<p style=\"direction: ltr;\">\n Kwale Eye Institute has conducted a clinical study on SLT laser in glaucoma among African eyes and was able to conclude the effectiveness of SLT laser in an African population; in addition, they acquired an SLT laser machine for the center through the study. The Kwale and Lions Sight first Eye centers have also been active in clinical research through residents in ophthalmology attending elective terms there, carrying out research for their dissertation.</p>\n<p style=\"direction: ltr;\">\n  </p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_explanation<p style=\"direction: ltr; \">\n Clinical sites have been chosen according to future markets planned for the devices</p>\n
      • other_details_regulatory_notapproved<p style=\"direction: ltr; \">\n ANSM - French National Agency for Medicines and Health Products Safety - Submitted on April 12th, 2020</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_approved<p style=\"direction: ltr; \">\n Health Canada (Canada) - approved on December 16th, 2019; Two sites in Canada</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_rejected<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • other_details_regulatory_halted<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • estimated_duration3 months recruitment + 12 months follow up = up to 15 months
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorHistorical Data
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • 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_states3
      • number_of_sites3
      • multi_country_listCanada, France, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_siteLions SightFirst hospital will recruit 8 participants for the study, KNH (Kenyatta National Hospital) will recruit 2 participants and The Kwale center will recruit 5 participants
      • total_participants_worldwide40
      • 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_patientsNo
      • 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_nameLily
      • investigator1_middle_nameAdhiambo
      • investigator1_family_nameNyamai
      • investigator1_qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
      • investigator1_professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
      • investigator1_telephone+254721710027
      • investigator1_emaillilynyamai@gmail.com
      • organisations_transferred_No
      • number_participants15
      • notification
      • approval_date10-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report<p>\n <strong>Introduction:</strong> This executive summary presents the key findings from the CorNeat EverPatch FIH clinical trial, conducted at two clinical sites in Kenya: Lions SightFirst Hospital in Nairobi and Kwale Eye Center in Mombasa. The trial aimed to evaluate the safety and efficacy of the CorNeat EverPatch, a novel medical device for ocular applications.</p>\n<p>\n <strong>Clinical Site: Lions SightFirst Hospital – Nairobi, Kenya:</strong></p>\n<p>\n Of the 8 implanted patients, 4 patients successfully completed the 12-month follow-up without noteworthy device-related complications. It's important to note that a unique surgical technique was employed, with sutures placed on top of the implanted patch, which may have affected the outcomes due to potential migration and increased susceptibility to breakdown.</p>\n<p>\n A single patient experienced patch exposure and complications leading to implant removal, primarily due to recurrent conjunctival erosion and infection. Another patient had patch exposure, leading to implant removal and replacement with another CorNeat EverPatch. No significant damage to ocular structures was noted in either case.</p>\n<p>\n Two additional patients exhibited recurring patch exposure, which resolved without surgical intervention. No other abnormalities were observed.</p>\n<p>\n <strong>Clinical Site: Kwale Eye Center – Mombasa, Kenya:</strong></p>\n<p>\n Five patients were enrolled to the trial out of which, 2 patients completed the follow-up period without any adverse reactions, indicating the safety of the CorNeat EverPatch in these cases.</p>\n<p>\n A single patient experienced a large conjunctival defect and patch exposure at 2 months post-op, which recurred after a failed attempt to close the gap with sutures. At 9 months post-op, the patch was surgically removed, replaced with a scleral patch, and covered with conjunctiva graft. No infection or adverse reactions to ocular tissues were observed.</p>\n<p>\n The trial excluded the two remaining patients, with one being lost to follow-up, and the other passing away during the trial from natural causes unrelated to the device or the procedure.</p>\n<p>\n  </p>\n
      • implication_results<p>\n The CorNeat EverPatch FIH clinical trial in Kenya has yielded mixed results. While some patients experienced successful implantation without complications, others faced patch exposure and device-related complications, leading to explantation. The unique surgical technique employed may have influenced outcomes. Further evaluation and refinement of the device and surgical approach are warranted to enhance the safety and efficacy profile. These findings will contribute valuable insights for the ongoing development and regulatory evaluation of the CorNeat EverPatch in Kenya.</p>\n<p>\n  </p>\n
      • quantity_imported20
      • quantity_dispensed20
      • quantity_destroyed6
      • quantity_exportedNA
      • balance_site0
      • final_date0000-00-00
      • modified2023-09-06 10:47:39
      • created2020-06-23 08:29:27
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id565
        • application_id914
        • given_nameLily
        • middle_nameAdhiambo
        • family_nameNyamai
        • qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
        • professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
        • telephone+254721710027
        • emaillilynyamai@gmail.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
    • SiteDetail(array)
      • 0(array)
        • id787
        • application_id914
        • county_id47
        • site_nameLions SightFirst Hospital
        • physical_addressKaptagat Rd, Nairobi, Kenya
        • contact_details+254721710027
        • contact_personDr. Lily Nyami
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id788
        • application_id914
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressHospital Rd, Nairobi, Kenya
        • contact_details+254722766233
        • contact_personDr. Owen Ogony
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id789
        • application_id914
        • county_id2
        • site_nameKwale Eye Centre
        • physical_addressLikoni-Ukunda Rd, Mombasa, Kenya
        • contact_details+25472220287
        • contact_personDr. Helen Roberts
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id2
          • county_nameKwale
          • created2012-05-31 16:15:21
          • modified2012-05-31 16:15:21
    • Sponsor(array)
      • 0(array)
        • id439
        • application_id914
        • sponsorCorNeat Vision
        • sponsor_typeIndustry
        • contact_personGerry Tal
        • addressHasheizaf 4, st Raanana, Israel
        • telephone_numberNA
        • fax_number
        • cell_number+972 52-356-2826
        • email_addressgerry@corneat.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
  • 1(array)
    • Application(array)
      • id1019
      • user_id73
      • trial_status_id5
      • abstract_of_study<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\"><strong>Background</strong></span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">SARS-CoV-2 is a novel coronavirus that emerged in the human population and has led to a pandemic of acute respiratory disease named COVID-19. The burden of SARS-CoV-2 morbidity and mortality has been catastrophic with greater than 2.8 million deaths recorded since first emerging in December 2019 among over 131.9 million confirmed cases (as of 06 April 2021) (2). In many locations, the rapid emergence of COVID-19 has overwhelmed the capacity of health systems to provide care for COVID-19-affected patients, let alone unaffected patients. Interventions to reduce transmission through reduction of population contact (also called social distancing) has had profound economic consequences. Safe and effective vaccines with sufficient supply would be vital to address the significant medical and societal burden caused by the pandemic. The CoV2 preS dTM-AS03 vaccines developed by Sanofi Pasteur utilize a recombinant protein approach in combination with an oil-in-water adjuvant, AS03 provided by GlaxoSmithKline (GSK). The CoV2 preS dTM-AS03 vaccines belong to the pharmacotherapeutic group of “covid19 vaccines”. The vaccines contain recombinant S protein, stabilized to maintain native prefusion trimer configuration as present on the viral envelope. The purpose of the study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) in adults 18 years of age and older in a multi-stage approach.</span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\"><strong>Methods</strong></span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">This study is designed to maximize representation of the broader population by minimizing exclusionary eligibility criteria and allowing the participation of individuals with a broad range of medical conditions, including controlled HIV infection, Hepatitis B and Hepatitis C, and conditions associated with an increased risk of severe COVID-19. It is also designed to be inclusive of other subpopulations affected by COVID-19, including older adults as well as ethnic and racial minorities. Participants will be screened for eligibility criteria at the time of inclusion and then randomized to either the investigational vaccine or placebo in a 1:1 ratio in each stage. • Stage 1: eligible participants will be randomized to receive either 2 injections of CoV2 preS dTM-AS03 (D614) vaccine or Placebo 1 (participants who receive the placebo as part of Stage 1) administered 21 days apart • Stage 2: eligible participants will be randomized to receive 2 injections of either CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine or Placebo 2 (participants who receive placebo as part of Stage 2) administered 21 days apart. Randomization will be stratified by age groups (18-59 years of age and 60 years of age and older), baseline SARS-CoV-2 rapid serodiagnostic test positivity, and site. In the event that the enrollment in Stage 1 overlaps with enrollment of Stage 2, participants will continue to be randomly allocated to one of the investigational vaccine groups and their matched placebo group in a 1:1 ratio. Approximately 37 430 participants are planned to be enrolled (8000 per study intervention group in Stage 1 and 10 715 per study intervention group in Stage 2)The duration </span><span style=\"font-size: 11px;\">of the study for each participant will be 365 days post-last injection (ie, approximately 386 days total). The study includes 8 visits at D01, D22, D43, D78, D134, D202, D292, and D387. Participants will be contacted once a week over the entire duration of the study to inquire about the development of symptoms of COVID-19-like-illness and to remind participants to contact study staff if they experience symptoms of COVID-19-like illness. Additional visits and procedures are included for participants with verified COVID-19-like illness.</span></p>\n
      • study_title<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of ageand older</span></p>\n
      • laymans_summary<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-This is a Phase 3 study (efficacy study) of two experimental vaccines against SARS-CoV-2. The full names are:</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">1. Monovalent: SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, monovalent D614 (CoV2 preS dTMAS03 [D614])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);margin-left: 40px;\">\n <span style=\"font-size:11px;\">2. Bivalent: SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, bivalent D614/B.1.351 (CoV2 preS dTM-AS03 [D614 + B.1.351])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-This study is also known as “VAT00008” or “CoVPN 3005.”</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccine is developed by Sanofi Pasteur, a company that produces vaccines against other diseases such as diphtheria, tetanus, pertussis, meningitis and</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">influenza.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccine will be manufactured using the same technology as is used to make an influenza vaccine that is licensed in the US for the prevention of influenza in</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">adults, marketed as Flublok .</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study will enroll about 37,500 participants globally.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The purpose of the study is to learn if:</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent symptomatic COVID-19 illness</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccines are safe</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccines make people too uncomfortable</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent infection with SARS-CoV-2</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent severe COVID-19 illness and hospitalization</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n
      • short_titleVAT00008
      • protocol_noECCT/21/06/05
      • version_no3.0
      • date_of_protocol18-05-2021
      • study_drugSARS-CoV2 prefusion Spike delta TM (CoV2 preS dTM): antigen formulation at (placeholder: 5 μg or15 μg) AS03: CoV2 preS dTM-AS03, Squalene-based adjuvant 2.1%
      • disease_conditionCOVID-19
      • 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_name0.9% normal saline
      • comparator_registeredyes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.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_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. Catherine Kiptinness
      • declaration_date111-06-2021
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date211-06-2021
      • placebo_presentYes
      • study_objectives<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Key Primary objectives</span></p>\n<ul>\n <li class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <p>\n <span style=\"font-size:11px;\">Primary Efficacy: To assess, in participants who are SARS</span><span style=\"font-size:11px;\">-CoV-2 na ve, the clinical efficacy of the CoV2 preS dTMAS03 </span><span style=\"font-size: 11px;\">vaccines for the prevention of symptomatic COVID-19 occurring ≥ 14 days after the second injection.<span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\">​</span></span></span></p>\n </li>\n <li class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <p>\n <span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\"><span style=\"font-size:11px;\">Primary Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placebo throughout the study</span></span></span></span></p>\n </li>\n</ul>\n
      • principal_inclusion_criteria<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Participants are eligible for the study only if all of the following criteria are met:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Age</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I01: Aged 18 years or older on the day of inclusion</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Type of participant and disease characteristics</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I02: For persons living with HIV, stable HIV infection determined by participant currently on antiretrovirals with CD4 count ></span><span style=\"font-size: 11px;\">200/mm3</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I03: SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I04: Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to </span><span style=\"font-size: 11px;\">receive the authorized vaccine available to them at the time of enrollment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Sex, contraceptive/barrier method and pregnancy testing requirements</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I05: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions </span><span style=\"font-size: 11px;\">applies:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at </span><span style=\"font-size: 11px;\">least 1 year or surgically sterile</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">OR</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to </span><span style=\"font-size: 11px;\">the first study intervention administration until at least 12 weeks after the second study intervention administration. </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by </span><span style=\"font-size: 11px;\">local regulation) within 25 hours before any dose of study intervention.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Informed Consent</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I06: Informed consent form has been signed and dated</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Other Inclusions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I07: Able to attend all visits and to comply with all study procedures</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I08: Covered by health insurance, only if required by local, regional or national regulations</span></p>\n<p class=\"p2\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 112, 0);\">\n  </p>\n
      • principal_exclusion_criteria<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Participants are not eligible for the study if any of the following criteria are met:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Medical conditions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E01: Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to a vaccine</span><span style=\"font-size: 11px;\">containing any of the same substances</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E02: Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on</span><span style=\"font-size: 11px;\">Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E03: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E04: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, </span><span style=\"font-size: 11px;\">contraindicating IM vaccination based on Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E05: Unstable acute or chronic illness that in the opinion of the Investigator or designee poses </span><span style=\"font-size: 11px;\">additional risk as a result of participation or that could interfere with the study procedures</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E06: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness </span><span style=\"font-size: 11px;\">(temperature ≥ 38.0 C [≥ 100.4 F]). A prospective</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">participant should not be included in the study until the condition has resolved or the </span><span style=\"font-size: 11px;\">febrile event has subsided </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">Prior/concomitant therapy</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E07: Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any </span><span style=\"font-size: 11px;\">vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza </span><span style=\"font-size: 11px;\">vaccination, which may be </span><span style=\"font-size: 11px;\">received at any time in relation to study intervention.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E08: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome </span><span style=\"font-size: 11px;\">coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERSCoV])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E09: Receipt of solid-organ or bone marrow transplants in the past 180 days</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E10: Receipt of anti-cancer chemotherapy in the last 90 days </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">Prior/concurrent clinical study experience</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E11: Participation at the time of study enrollment (or in the 30 days preceding the first study </span><span style=\"font-size: 11px;\">vaccination) or planned participation during the present study period in another clinical</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">study investigating a vaccine, drug, medical device, or medical procedure</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Other exclusions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E12: Deprived of freedom by an administrative or court order, or in an emergency setting, or </span><span style=\"font-size: 11px;\">hospitalized involuntarily</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E13: Identified as an Investigator or employee of the Investigator or study center with direct </span><span style=\"font-size: 11px;\">involvement in the proposed study, or identified as an immediate family member (ie,</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">parent, spouse, natural or adopted child) of the Investigator or employee with direct </span><span style=\"font-size: 11px;\">involvement in the proposed study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Depending on country regulations and feasibility, if the participant has a primary physician who is not the Investigator, the </span><span style=\"font-size: 11px;\">site may contact this physician with the participant’s consent to inform him / her of the participant’s participation in the </span><span style=\"font-size: 11px;\">study. In addition, the site may ask this primary physician to verify exclusion criteria including but not limited to previous</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">therapies, such as previous vaccines.</span></p>\n
      • primary_end_points<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <strong><span style=\"font-size:11px;\">Primary Efficacy Endpoints</span></strong></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Occurrences of symptomatic COVID-19</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <strong><span style=\"font-size:11px;\">Primary Safety Endpoints</span></strong></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">For participants in the Reactogenicity Subset:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of solicited (pre-listed in the participant’s diary card / electronic diary card [DC/eDC] and [electronic] Case Report </span><span style=\"font-size: 11px;\">Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days after each vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of non-serious unsolicited adverse events (AEs) reported up to 21 days after the last vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">For all participants in the study:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of unsolicited injection site and systemic AEs reported in the 30 minutes after each </span><span style=\"font-size: 11px;\">vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of medically-attended adverse events (MAAEs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of serious adverse events (SAEs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of adverse events of special interest (AESIs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of virologically-confirmed SARS-CoV-2 infections and/or symptomatic COVID-19</span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyPhase III Vaccine study
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase III Vaccine study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n  </p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Site Co-Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">                                                Dr. Elizabeth Irungu MBChB, MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Lead Physician for the study: Dr. Stanley Ndwiga<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Regulatory Lead: Peter<span class=\"apple-converted-space\"> </span>Mogere<o:p></o:p></span></p>\n
      • other_details_explanation<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - trial is being conducted in the host country</span></p>\n
      • other_details_regulatory_notapproved<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Application to the CBER (USA) on 18 May 2021</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">India: HA submission (Central Drugs Standard Control Organization (CDSCO)) = 13-May-21</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Mexico: HA submission (Comisi n Federal para la Protecci n Contra Riesgos Sanitarios) = 24-May-21</span></p>\n
      • other_details_regulatory_approved<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - no approvals have been given yet</span></p>\n
      • other_details_regulatory_rejected<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - no rejections</span></p>\n
      • other_details_regulatory_halted<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - study has not been halted</span></p>\n
      • estimated_duration386 days
      • 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_comparatorSOLUTION FOR INJECTION
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR-PHRD THIKA PROJECT
      • single_site_physical_addressOAU ROAD, SECTION 9 THIKA
      • single_site_contact_personDR. CATHERINE KIPTINNESS
      • single_site_telephone0721 323898
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states14
      • number_of_sites
      • multi_country_listUSA, Honduras, Dominican Rep, Mexico, Colombia, Japan, India, Pakistan, Sri Lanka, Egypt , Uganda, Kenya, Ghana, Nigeria
      • data_monitoring_committeeYes
      • total_enrolment_per_site250
      • total_participants_worldwide37430
      • 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_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_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBchB,MPH,PHD
      • investigator1_professional_addressCentre for Respiratory Diseases Research, Kenya Medical Research Institute, P.O.Box 47855-00100G.P.O., Nairobi.
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants2000
      • notification<ol>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Provide time of commitment for submission of Phase II clinical study report:</span></span></p>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Brief CSR (Day 01 – Day 43 Key Data): Already completed and submitted, report dated 16 May 2021)<span style=\"color:#0000cd;\"> </span><span style=\"color:#0000cd;\">We have <strong>Attached the brief CSR as well as Appendices (safety listings & Deaths/SAEs)</strong></span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Interim CSR (Day 01 – Day 43): 06 AUG 2021</span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Interim CSR (Day 202 Visit): 14 JAN 2022</span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Final CSR: 14 OCT 2022</span></span></span></p>\n </li>\n </ol>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span lang=\"EN-US\" style=\"caret-color: rgb(0, 0, 0); color: rgb(0, 0, 0); text-size-adjust: auto;\">It has been noted that only section 2.4 of the dossier has been provided. Provide full IMPD dossier since this is a Phase III study<span class=\"Apple-converted-space\"> </span></span><span lang=\"en-KE\" style=\"text-size-adjust: auto; color: black;\">study:</span><span style=\"color:#0000ff;\"><span lang=\"EN-US\" style=\"text-size-adjust: auto;\"> </span></span><span style=\"color:#0000cd;\"><span lang=\"EN-US\" style=\"text-size-adjust: auto;\">In terms of format, we initially did not prepare an “IMPD” format for VAT08 but an IND/CTD format. I would like to highlight that the IND/CTD sections cover all the information usually included in the IMPD. Please add this to the response section</span></span></span></span></p>\n </li>\n</ol>\n
      • approval_date02-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:660px;\" width=\"660\">\n <tbody>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Title:</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older as a primary series and open-label extension to assess immunogenicity, safety, and efficacy of a monovalent booster dose of the SARS-CoV2 Adjuvanted Recombinant Protein Vaccine.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Prtocol Number:</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n VAT00008</p>\n <p>\n <strong>ECCT REF</strong>: ECCT/21/06/05</p>\n <p>\n <strong>ERC REF:</strong> KEMRI/SERU/CCR/0228/4267</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Sponsor</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n Sanofi Pasteur Inc.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Objectives:</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <ul>\n <li>\n <strong>The primary objectives:</strong></li>\n </ul>\n <ol>\n <li>\n To assess in SARS-CoV-2-naïve adults, the clinical efficacy of the CoV2 preS dTM – AS03 vaccines for the prevention of symptomatic COVID – 19 occurring <u>></u> 14 days after the second injection.</li>\n <li>\n To assess the safety profile of CoV2 preS dTM – AS03 vaccines compared to placebo throughout the study duration.</li>\n </ol>\n <ul>\n <li>\n <strong>Crossover/Booster objectives:</strong></li>\n </ul>\n <ol>\n <li>\n <strong>Secondary Immunogenicity: </strong>To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.</li>\n <li>\n <strong>Secondary Safety: </strong></li>\n </ol>\n <ul>\n <li>\n To assess the safety of the CoV2 preS dTM – AS03 vaccines after primary series or booster  vaccination.</li>\n <li>\n To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.</li>\n <li>\n To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Design</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n This Phase III study was a multi-country, multi-center, randomized, modified double-blind, placebo-controlled, multi-stage trial. It evaluated the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) in adults aged 18 years and older. The study consisted of two main stages:</p>\n <ul>\n <li>\n <strong>Stage 1:</strong> Assessment of the AS03 adjuvanted monovalent vaccine containing the prefusion S protein from the prototype (D614) variant against a placebo control.</li>\n <li>\n <strong>Stage 2:</strong> Evaluation of the AS03 adjuvanted bivalent vaccine containing prefusion S protein from the prototype (D614) and Beta (B.1.351) variants against a placebo control.</li>\n <li>\n <strong>Crossover/Booster Phase:</strong> Open-label extension to assess the safety, immunogenicity, and efficacy of a monovalent booster dose in participants who completed the primary study phase.</li>\n <li>\n The <strong>primary endpoint</strong> was the prevention of virologically confirmed symptomatic COVID-19 occurring <strong>≥14 days post-second dose</strong>.</li>\n <li>\n Safety and reactogenicity were also assessed.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Population</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n Participants were categorized based on prior SARS-CoV-2 infection as:</p>\n <ul>\n <li>\n <strong>Naïve:</strong> No prior infection evidence at the time of enrollment.</li>\n <li>\n <strong>Non-naïve:</strong> Prior infection confirmed via serological or virological testing.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Key Findings</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n <strong>Enrollment and Follow-Up:</strong></p>\n <ul>\n <li>\n <strong>10,114 participants</strong> received at least one dose.</li>\n <li>\n <strong>9,441 participants</strong> completed both doses.</li>\n <li>\n <strong>2,108 (20.8%) participants were SARS-CoV-2 naïve</strong> at the time of enrollment.</li>\n </ul>\n <p>\n <strong>Efficacy:</strong></p>\n <ul>\n <li>\n <strong>Overall vaccine efficacy (VE) against symptomatic COVID-19 was 15.3% (95% CI: -15.8 to 38.2)</strong> in SARS-CoV-2 naïve individuals, not meeting the predefined efficacy threshold.</li>\n <li>\n VE was <strong>52.7% (95% CI: 31.2 to 67.9) in non-naïve participants</strong> (previously infected individuals), indicating greater protection in previously exposed populations.</li>\n <li>\n VE against the <strong>Delta variant</strong> was <strong>64.2% (95% CI: 10.2 to 87.4) in naïve participants</strong>.</li>\n <li>\n VE against the <strong>Omicron variant</strong> was <strong>-44.5% (95% CI: -141.1 to 12.0),</strong> showing reduced protection against this highly immune-evasive strain.</li>\n </ul>\n <p>\n <strong>Safety and Tolerability:</strong></p>\n <ul>\n <li>\n The vaccine was <strong>well-tolerated</strong> with an <strong>acceptable safety profile</strong>.</li>\n <li>\n No significant increase in severe adverse events (SAEs), adverse events of special interest (AESIs), or medically attended adverse events (MAAEs) was observed compared to placebo.</li>\n <li>\n No cases of <strong>myocarditis, pericarditis, Guillain-Barré syndrome, or thrombosis with thrombocytopenia syndrome</strong> were reported.</li>\n <li>\n <strong>No deaths</strong> were observed in the vaccine group, while <strong>nine deaths</strong> were reported in the placebo group (none attributed to the vaccine).</li>\n </ul>\n <p>\n <strong>Immunogenicity:</strong></p>\n <ul>\n <li>\n The vaccine <strong>elicited strong neutralizing antibody responses</strong> in non-naïve participants.</li>\n <li>\n <strong>Geometric mean titer (GMT) of neutralizing antibodies</strong> was significantly higher in <strong>non-naïve participants (9109)</strong> compared to <strong>naïve participants (1409)</strong> at <strong>Day 43</strong>.</li>\n <li>\n Immune responses were comparable to other first-generation COVID-19 vaccines in terms of neutralizing activity against ancestral strains.</li>\n </ul>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Conclusions and Implications</strong></p>\n </td>\n <td style=\"width:540px;\">\n <ul>\n <li>\n The study confirms that <strong>prior SARS-CoV-2 infection enhances vaccine-induced protection</strong>, with <strong>higher efficacy in non-naïve individuals</strong>.</li>\n <li>\n The <strong>D614 monovalent vaccine was less effective in SARS-CoV-2 naïve individuals</strong>, particularly against Omicron variants, highlighting the need for updated vaccine formulations targeting contemporary strains.</li>\n <li>\n These findings contribute to the evolving <strong>global COVID-19 vaccination strategy</strong>, reinforcing the need for <strong>variant-adapted vaccines</strong> and <strong>booster doses</strong>.</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • implication_results<p>\n There were no any implications from the study results as the sponsor has decided not to manufacture, supply, or further develop the vaccine due to decreased global public health demand for COVID-19 vaccines.</p>\n
      • quantity_imported570 kits
      • quantity_dispensed450
      • quantity_destroyedNone
      • quantity_exported120 kits
      • balance_siteNone
      • final_date0000-00-00
      • modified2025-02-27 14:25:38
      • created2021-06-11 02:57:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id665
        • application_id1019
        • given_nameNelly Rwamba
        • middle_name
        • family_nameMugo
        • qualificationMBCHB, MPH
        • professional_addressrwamba@uw.edu
        • telephone0733629665
        • emailrwamba@uw.edu
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
    • SiteDetail(array)
      • 0(array)
        • id923
        • application_id1019
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id509
        • application_id1019
        • sponsorSanofi Pasteur
        • sponsor_typeOthers
        • contact_personJames Okwach
        • addressDiscovery Drive, Swiftwater, PA 18370-0187, USA
        • telephone_number+254717721518
        • fax_number
        • cell_number+254717721518
        • email_addressOkwachJames@praintl.com
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
  • 2(array)
    • Application(array)
      • id1225
      • user_id81
      • trial_status_id1
      • abstract_of_study<p>\n Supplementation with multiple micronutrients has been shown to reduce prevalence of low birth weight and small for gestation age babies when given to pregnant women in nutritionally deficient populations. There are few studies measuring markers of microntrient status in pregnant women in LMICs before and after supplementation but evidence from the JiVita trial in Bangladesh suggests that the current dose formulation is insufficient to achieve repletion. Bangladesh is not a malaria endemic area and deficiencies may vary according to geographic location, hence the need for studies in Kenya.  The proposed trial will be a dose-finding trial of multiple micronutrient supplements in the form of powder to be taken in water with 3 arms: current standard of care and 2 arms: test dose 1 with moderately increased doses and  test dose 2 with higher doses  but below the safe upper level. Pharmacokinetic analysis of micronutrient markers using both rich and sparse sampling timepoints will predict optimal doses. The trial will take place in women of reproductive age aged 18-35 years and consist of 2 cohorts of 108 women: non-pregnant and pregnant women living in 2 locations of Kilifi North subcounty. Tolerability and safety of the supplements will be monitored.</p>\n<p>\n  </p>\n
      • study_title<p class=\"16\" style=\"margin-left:0.0000pt;\">\n <span style=\"font-size:12px;\"><span style=\"font-family: "Times New Roman";\">Optimizing nutrient supplementation among pregnant and reproductive age women in Kenya (Virutubisho)</span></span><span style=\"font-family: "Times New Roman"; font-size: 14pt;\"><o:p></o:p></span></p>\n
      • laymans_summary<p>\n <strong>What is the problem/background?</strong></p>\n<p>\n Deficiencies of essential vitamins and minerals (micronutrients) can occur in women regardless of their weight and may result in poor health, pregnancy outcomes and development and growth of their children. The World Health Organization recommends the use of multiple micronutrient supplements for pregnant women in nutritionally deficient populations, commonly known as UNIMMAP (United Nations International Multiple Micronutrient Antenatal Programme) formulation, to correct deficiencies and improve birth outcomes. The supplement doses are based on the recommended daily intake of healthy populations in North America. Data from supplementation studies in The Gambia and Bangladesh indicate that the dose of micronutrients in UNIMMAP may not be adequate for pregnant women in low-or middle-income countries (LMICs) with inadequate diets. The Kenya National Micronutrient Survey of 2011 reported micronutrient assay results for vitamin A, vitamin B12, folic acid iodine, iron, and zinc but the number of   pregnant women providing samples was small (n=111).</p>\n<p>\n  </p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n What is the optimal dose of micronutrients to supplement the diet of women of reproductive age and pregnant women in coastal Kenya?</p>\n<p>\n  </p>\n<p>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will take place in Tezo and Ngerenya locations of Kilifi North sub-county. It will involve 216 women aged between 18 to 35 years, 108 non- pregnant and 108 pregnant. The non-pregnant women will be identified from the population census of the Kilifi Health and Demographic Surveillance System (KHDSS) and those identified by community health volunteers and healthworkers. The pregnant women will be selected from the KHDSS census data, those identified by community health volunteers and health workers, and also those attending for antenatal care at Mtondia, and Ngerenya dispensaries in the first 20 weeks of their pregnancy.  </p>\n<p>\n  </p>\n<p>\n <em>Acceptability pre-study</em></p>\n<p>\n In order to choose the most acceptable taste of the supplement, a pre-trial acceptability study of different flavours will be tested on 90 pregnant women volunteers attending antenatal clinic. An interviewer will ask the women to rate each sample on a scale of 1 to 7 according to how much they like or dislike it.  Analysis of the women’s preferences will be used to choose the formulation of the investigational product for the main trial.</p>\n<p>\n  </p>\n<p>\n <em>Evaluation by implementers of the study</em></p>\n<p>\n Up to 30 study staff, health workers, and community health volunteers will take part in workshops and interviews as part of evaluation of implementation of the study. Consent for audio recording will be requested.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n <em>Acceptability testing of formulations</em></p>\n<p>\n Prior to the main trial, 9 different formulations of the supplement in solution will be tested for taste and acceptability. Ninety pregnant women attending antenatal clinics will be asked for written informed consent to attend a single session where they will each taste 4 of the solutions allocated at random, rate them on a 7 point grading system for acceptability and give their comments on the taste.</p>\n<p>\n  </p>\n<p>\n <em>Screening for eligibility </em></p>\n<p>\n For the main trial women aged 18 to 35 who are interested in participating will be invited to their local dispensary where they will be informed about the study and asked for written consent on screening procedures. They will be asked about their health, medication, and pregnancy status, have their height, weight and mid-upper arm circumference measured, and have a blood sample taken (2ml/half teaspoonful), for full blood count, and biochemistry profile (for kidney and liver function) and a urine sample (5ml/1 teaspoonful) for pregnancy test. Pregnant women will be invited to Kilifi County Hospital for an ultrasound to confirm pregnancy and estimate the gestation of their pregnancy. Results of screening tests will be fed back to women by a fieldworker at their home and those who are eligible will be invited to come to the clinic with their partner or next of kin to hear more about the study procedures.</p>\n<p>\n  </p>\n<p>\n <em>Enrolment</em></p>\n<p>\n At the clinic, women who are eligible will be asked for consent for the study. Those who consent will be enrolled and given an appointment to visit the dispensary for baseline questionnaire and blood sampling (10ml for vitamins and minerals, signs of infection, HIV, malaria, and storage for future studies), urine sampling (5ml) for iodine status assessment and stool (for worms and storage for future studies) tests, before receiving the first dose of supplements. Pregnant women will also have the remaining tests in the standard antenatal profile (blood group, blood glucose, syphilis, and urine protein and glucose) performed from the enrolment samples (same volume).</p>\n<p>\n  </p>\n<p>\n <em>Daily supplements with directly observed treatment</em></p>\n<p>\n The women will be given daily supplements in the form of multiple micronutrient powder dissolved in water. Non-pregnant women will receive supplements for 3 months. and the pregnant women from enrolment (before 20 weeks’ gestation) up to delivery. Women will be randomly allocated to one of 3 dose levels: the control is 1 recommended daily allowance (standard of care) of 15 micronutrients, test dose 1: moderately increased doses of 2 micronutrients or test dose 2: higher doses at safe upper levels of 2 micronutrients. A fieldworker will visit the participant’s home at a convenient time every day with the supplements and observe that they have been taken.</p>\n<p>\n  </p>\n<p>\n <em>Measurement of micronutrient levels </em></p>\n<p>\n Non- pregnant participants will be divided into 2 groups for micronutrient measurement:  the first 36 women will be allocated to the “rich” sampling group which will be sampled at more frequent (5) visits than the remaining 72 women who will be in the less frequent (2 visits) “sparse” sampling group. Women in the rich sampling group will be asked to attend their local dispensary for blood, urine and stool sampling.  For blood and urine sampling, samples will be collected on days 0, 7, 14, 6 weeks and 3 months. Women in the sparse sampling group will be asked to attend their local dispensary for blood, urine and stool sampling at day 0 and 3 months only. The pregnant women will also be divided into more frequent (“rich”, the first 36 women), 7 visits, and less frequent (“sparse” the remaining 72 women) sampling groups, 3 visits, for micronutrient measurement, with rich sampling groups attending on day 0, 7, 14, and 6 weeks, 3 and 5 months and at delivery if giving birth in KCH. The sparse sampling group will be tested at day 0, month 3 and at delivery (KCH).  </p>\n<p>\n Total volumes of blood sampled during the study period for non-pregnant women will be 56 ml (4 tablespoonful) in the rich and 25 ml (2 tablespoonfuls) in the sparse sampling groups. Total volumes of blood sampled during the study period for pregnant women will be 74 ml (5 tablespoonfuls) in the rich and 35 ml (2 tablespoonfuls) in the sparse groups. In addition, 2ml (half teaspoonful) of cord blood will be taken from the umbilical cord of infants born at KCH. The volumes taken during the study are not harmful.</p>\n<p>\n  </p>\n<p>\n <em>Interim safety analysis</em></p>\n<p>\n When the first 36 women of each cohort (non-pregnant and pregnant) have received 6 weeks of supplement, an additional volume of blood (2ml/half teaspoonful) will be taken for rapid analysis of micronutrient levels. The results will be reported to the safety committee overseeing the study.</p>\n<p>\n  </p>\n<p>\n <em>Samples for exploratory outcomes</em></p>\n<p>\n Some of the stool sample, and the cord blood sample will be stored for later analysis.  In addition, in the pregnant women groups a 15ml (3 teaspoonfuls) sample of breastmilk 1 month after delivery will be collected and stored for future analysis.</p>\n<p>\n  </p>\n<p>\n <em>Dietary assessment</em></p>\n<p>\n Women will be visited at home on a monthly basis during supplementation and asked questions on what they have eaten in the previous 24 hours. This will provide information on micronutrient intake from food.</p>\n<p>\n  </p>\n<p>\n <em>Qualitative assessments</em></p>\n<p>\n Interim assessment: When the first 36 participants in each cohort (non-pregnant and pregnant) have received the supplements for 4 weeks they will be invited to group discussions to seek their views on tolerability and acceptability of the supplements and any challenges they faced in participating in the trial. In addition, at the same time, a half day workshop for implementers will be held to get feedback on the progress of the trial. The workshop for implementers will be repeated at the end of the trial. Participants who withdraw from the study will be invited to an indepth interview to explore their reasons for withdrawing.</p>\n<p>\n  </p>\n<p>\n <strong>What are the benefits and risks/costs of the study for those involved? </strong></p>\n<p>\n Participants will receive multiple micronutrient supplements which have known health benefits but have not yet been rolled out in the national antenatal programme. Participants will also have close oversight from the study team and payment of outpatient and inpatient treatment costs for acute illnesses occurring during the study period. Risks of the study include the inconvenience of multiple trips to the dispensary for sampling, and potential for minor discomfort and infection from blood sampling. Daily home visits will be expected to last less than half an hour. Dietary recall interviews (twice monthly), birth and 1month postpartum home visits should each take less than 2 hours. Fares at public transport rate will be reimbursed for all study visits, and out of pocket expenses (500 Kes for study visits lasting more than 3 hours) will be reimbursed.  Potential intolerance of supplementation e.g.  nausea and diarrhoea, will be closely monitored by the study team daily. There is a small potential risk from the micronutrient supplements to the women but doses are below the known safe upper levels in pregnancy. Participants will be followed up for adverse events at each contact with them.</p>\n<p>\n <strong>How will the study benefit society</strong>?</p>\n<p>\n The study will provide new knowledge on optimal dosing of multiple micronutrients for adult women. It will also provide data on nutritional status of adult women in this community.When does the study start and finish?</p>\n<p>\n The study will start upon receipt of ethical and regulatory approval; data collection, analysis and write up will take place over 3 years.</p>\n
      • short_titleMicronutrient supplementation
      • protocol_noECCT/23/03/01
      • version_no3.41
      • date_of_protocol09-01-2023
      • study_drugMultiple micronutrients supplement
      • disease_conditionMicronutrient deficiency
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameMicronutrients
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • 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_addendum0
      • 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_applicantFREDRICK OPEL
      • declaration_date128-02-2023
      • declaration_principal_investigatorDR. MARTHA KAENI MWANGOME
      • declaration_date228-02-2023
      • placebo_presentNo
      • study_objectives<p>\n <strong>Objectives</strong><strong>:</strong></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Primary objective:</strong></p>\n<p>\n to determine optimal dosing of multiple micronutrient supplements (MMS) to correct micronutrient deficiencies among pregnant and non-pregnant women of reproductive age in Kilifi County, Kenya</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives: </strong><br />\n i) To describe tolerability and safety of micronutrients at different doses, including birth outcomes</p>\n<p>\n ii) to collect and store infant cord blood and maternal breastmilk for future analysis of micronutrient levels in a separate study</p>\n<p>\n iii) to establish a follow up cohort for evaluation of growth and nutritional status of infants in a separate study</p>\n<p>\n  </p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n i) to examine the impact of micronutrient supplementation on the maternal microbiome, inflammatory and physiological markers</p>\n<p>\n ii) to examine effects of maternal genomics on achieving nutrient repletion</p>\n<p>\n iii) to examine infant size at birth and growth to one month of age</p>\n
      • principal_inclusion_criteria<h2>\n <strong>Inclusion criteria</strong></h2>\n<p>\n <strong>Non-pregnant cohort</strong></p>\n<p>\n Women aged 18-35 years</p>\n<p>\n Not pregnant and not lactating</p>\n<p>\n Not intending to move away for 6 months</p>\n<p>\n Negative pregnancy test and not intending to get pregnant during study</p>\n<p>\n Able and willing (in the investigator’s opinion) to comply with all study requirements</p>\n<p>\n <strong>Pregnant women cohort</strong></p>\n<p>\n Women aged 18-35 years</p>\n<p>\n Pregnant with singleton pregnancy from 14 to less than or equal to 20 weeks gestation</p>\n<p>\n Not intending to move away for 6 months</p>\n<p>\n Able and willing (in the investigator’s opinion) to comply with all study requirements</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<h2>\n <strong> Exclusion criteria</strong></h2>\n<p>\n <strong>Non-pregnant women </strong></p>\n<p>\n Known intolerance or allergy to constituents of IP</p>\n<p>\n Moderate or severe anaemia (Hb<8g/dL) or other nutritional conditions requiring immediate treatment</p>\n<p>\n Unwilling to substitute regular MMS for the study product</p>\n<p>\n  </p>\n<p>\n <strong>Pregnant women </strong></p>\n<p>\n Known intolerance or allergy to constituents of IP</p>\n<p style=\"margin-left:-18.0000pt;\">\n Mu  Multiple pregnancy</p>\n<p>\n Moderate or severe anaemia (Hb<7g/dL) or other nutritional conditions requiring immediate treatment</p>\n<p>\n Unwilling to substitute regular MMS for the study product</p>\n<p>\n Foetal concerns suspected at the screening dating ultrasound scan</p>\n
      • primary_end_points<p>\n <u><strong>Primary Endpoint</strong></u></p>\n<p>\n Optimal micronutrient doses will be predicted from PK analysis. The PK model will be used to simulate a dose which achieves concentrations within accepted reference ranges for each micronutrient (<strong>Table 5 of markers of micronutrient status</strong>).</p>\n<p>\n  </p>\n<p>\n Samples will be analysed for haematology (full blood count), biochemistry (Na, K, Ca, Mg, PO₄, albumin, renal and liver function tests), Micronutrient status (zinc, iron, ferritin, transferrin receptor, vitamin B12, folate, vit B6, retinol, beta-carotene, vitamin E, vitamin D, vitamin C, vitamin K, thiamine, riboflavin, niacin, urinary iodide, copper, selenium, calcium, phosphorus, pantothenic acid, biotin, choline, potassium, manganese and magnesium), inflammatory markers (AGP, CRP), and malaria parasites.</p>\n<p>\n  </p>\n<p>\n At delivery or within 48 hours the study staff member will take samples of mother’s blood and urine at the health facility or at a home visit for haematology (full blood count), biochemistry (Na, K, Ca, Mg, PO₄, albumin, renal and liver function tests), micronutrient status (zinc, iron, ferritin, transferrin receptor, vitamin B12, folate, vit B6, retinol, beta-carotene, vitamin E, vitamin D, vitamin C, vitamin K, thiamine, riboflavin, niacin, urinary iodide, copper, selenium, calcium, phosphorus, pantothenic acid, biotin, choline, potassium, manganese and magnesium) inflammatory markers (AGP, CRP) and malaria parasites.</p>\n<p>\n  </p>\n<p>\n If a mother gives birth at KCH and has given consent on the relevant tick box on the ICF a sample of cord blood (2ml) will be obtained and stored for future analysis of micronutrient and inflammatory markers and malaria parasites</p>\n<p>\n  under a separate study protocol.</p>\n<p>\n At 1 month postpartum: 15ml breastmilk will be sampled and stored for future analysis of micronutrients markers, human milk oligosaccharides, exosomes, and proteome. A PhD student will be recruited to explore the effect of MMS on breastfeeding and breastmilk.</p>\n<p>\n  </p>\n<p>\n Samples for haematology, malaria parasites, biochemistry, and inflammatory markers will be analysed at KWTRP laboratories in Kilifi. Samples for micronutrient assays will be sent in batches during and at the end of the intervention to The Metabolomics Innovation Center in Canada because they require specialist equipment not available in Kenya.</p>\n<p>\n <strong>Table </strong><strong>5</strong><strong>: Micronutrient status indicators </strong></p>\n<p>\n  </p>\n<table border=\"0\" cellspacing=\"0\" style=\"width:707px;\">\n <tbody>\n <tr>\n <td style=\"width:89px;\">\n <p>\n <strong>Nutrient</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n <strong>Marker</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n <strong>Cut off for adequacy</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n <strong>Indicator of excess</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n <strong>Notes</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin A</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Retinol µmol/L, β-Carotene, µmol/L</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n serum retinol 0.7 μmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n serum retinol >3.49µmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Blood levels correlate poorly with toxicity, diagnosis is primarily clinical(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin D</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n 25 hydroxyVitamin D (25(OH)D nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 25-30nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >200 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n >400 nmol/L associated with hypercalcemia(33)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin E</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n α- tocopherol µmol/L, α- tocopherol: cholesterol ratio µmol/L/mmol</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n α- tocopherol 12 μmol/L; α- tocopherol: cholesterol ratio 2.2 μmol/L/mmol</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no set cut off for toxicity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B1 (Thiamine)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n RBC or whole blood thiamine diphosphate, Erythrocyte transketolase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n whole blood thiamine diphosphate 70 nmol/L; ETK activity ratio 1.25</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Excess is excreted in urine</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B2 (Riboflavin)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma riboflavin, Erythrocyte glutathione reductase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Plasma riboflavin 1mcg/L; EGR activity coefficient 1.4</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Excess is excreted in urine</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B3 (Niacin)</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Plasma nicotinic acid plus plasma nicotinamide (µg/mL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 0.5 µg/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n liver transaminases  may rise with extremely high doses(34)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B12</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Total cobalamin pmol/L, Holo-transcobalamin, Methylmalonic acid, Homocysteine</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Total cobalamin 150 pmol/L; methylmalonic acid 0.26 μmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Total cobalamin >701 pmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Andres (35)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B6</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n pyridoxal-5’-phosphate nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 20 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >110 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Tynes (36)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Folate</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Total plasma/serum folate nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 10 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >45.3 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: WHO (37)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin C</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma ascorbic acid (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 0.4 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >3mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic (38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Iron</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Ferritin µg/L, Transferrin receptor mg/L, TfR:ferritin index mg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n ferritin 15 μg/L; transferrin receptor 15 μg/L; TfR:ferritin index 2.2</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Ferritin > 200µg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Adams (39) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Zinc</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum zinc (ug/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 50 ug/dL in pregnant women</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n  > 110 ug/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Iodine</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Thyroglobulin µg/L, Urinary iodide</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n urinary iodide 150 μg/L pregnant women</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Urinary iodide≥200ug/L (>250 ug/L in pregnant women)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: WHO (42) >299 excessive risk of adverse health consequences</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Selenium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum selenium (ng/mL), Glutathione peroxidase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Serum selenium <40 ng/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n serum selenium >150 ng/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Copper</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum copper (ug/mL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 0.75 ug/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n  >1.45 ug/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic (38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Calcium</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Total serum calcium (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 8.5 mg/dL (2.2. mmol/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >10.5 mg/dL [2.63 mmol/L]</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: NIH (ODS)(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Phosphorus</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Serum phosphate (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 2.8 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >4.5 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin K</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Decarboxyprothombin/PIVKA-II (µg/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 0.1 µg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n none established</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n  Pantothenic acid</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma pantothenic acid</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n None Specified</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >147ug/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Biotin</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum biotin (mg/dL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n not established; urinary excretion of biotin</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: NIH (ODS)(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Choline</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma choline</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >20 µmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Gossell-Williams(40)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Potassium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma potassium mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 3.5 mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >5.5 mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Manganese</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum manganese (ug/dL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n 3.66 ug/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Mayo Clinic(38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Magnesium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum magnesium (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 1.7 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n 2.3 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Mayo Clinic(38)</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table align=\"left\" border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:654px;\" width=\"654\">\n <tbody>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:45px;\">\n <p>\n <strong>Kilifi </strong></p>\n <p>\n  </p>\n <p>\n <strong>Staffing </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:15px;\">\n <p>\n <strong>Staff </strong></p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n <strong>Names </strong></p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n <strong>Qualifications </strong></p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n <strong>Experience </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Principal Investigator (1)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Martha Mwangome</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p style=\"margin-left:.15pt;\">\n M.Sc. PHD (Nutritional Epidemiology).</p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, site management and Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:144px;height:24px;\">\n <p>\n Medical officers (2)</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. James Berkley</p>\n <p>\n  </p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n MBBS MTropMed MRCP MD FRCPCH FMedSci</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, Professor of Paediatrics,</p>\n <p style=\"margin-left:.1pt;\">\n Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Alison Talbert</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n MBBS, MRCP, M.Sc. Epidemiology.</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Pharmacist (1)</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Jimmy Shangala</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n BPharm, MPharm</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Lab Manager</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p>\n  Jacqueline Waeni</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n M.Sc., PHD-Systems Biology and Bioinformatics (Candidate)</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Lab experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Data Manager</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Narshion Ngao</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n B.Sc. IT, M.Sc. IT</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Research data management experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Fredrick Opel</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n B.Sc. Public health, Dip. Clinical Medicine</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, site management</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Clinicians (1)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p>\n Dip. Clinical</p>\n <p style=\"margin-left:.15pt;\">\n Medicine </p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trials, data collection, site</p>\n <p style=\"margin-left:.1pt;\">\n management, Ultrasonography.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Nurses (3)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p>\n Dip. Nursing</p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical trials, sample collection and management</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"height:14px;\">\n <p>\n Senior Field worker (2)</p>\n </td>\n <td style=\"width:139px;height:14px;\">\n <p style=\"margin-left:.05pt;\">\n Nichodemus Wara</p>\n </td>\n <td style=\"width:131px;height:14px;\">\n <p style=\"margin-left:.15pt;\">\n KCSE</p>\n </td>\n <td style=\"width:240px;height:14px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, team lead, field work, data entry, Rider,</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:14px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:14px;\">\n <p style=\"margin-left:.15pt;\">\n KSCE</p>\n </td>\n <td style=\"width:240px;height:14px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, team lead, field work, data entry, Rider</p>\n </td>\n </tr>\n <tr>\n <td style=\"height:15px;\">\n <p>\n Field worker (18)</p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n KCSE</p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, field work, data entry, Rider,</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:144px;height:15px;\">\n <p>\n Senior Data Supervisor (2)</p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n Amos Fondo</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n BSc. Computer Science</p>\n <p style=\"margin-left:.15pt;\">\n  </p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data entry, data cleaning, query management</p>\n <p style=\"margin-left:.1pt;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:15px;\">\n <p>\n Eunice Kahindi</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n BSc. Computer Science</p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data entry, data cleaning, query management</p>\n <p style=\"margin-left:.1pt;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:37px;\">\n <p>\n Lab technologist (1)</p>\n </td>\n <td style=\"width:139px;height:37px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:37px;\">\n <p>\n Dip. Lab technology</p>\n </td>\n <td style=\"width:240px;height:37px;\">\n <p>\n Microbiology, AST testing, biorepository in a research Lab.</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:74px;\">\n <p>\n <strong>Site Facilities </strong></p>\n <ul>\n <li>\n Office space with adequate resources i.e. furniture, internet connectivity and computers</li>\n <li>\n Well-spaced clinical rooms and phlebotomy unit.</li>\n <li>\n Access to Programme transport for community follow up and administration of DOTs.</li>\n <li>\n Laboratory network – Full microbiology, hematology, parasitology, and immunology.</li>\n <li>\n Kilifi County Hospital: Maternity ward, acute room, maternal and child health clinic, Mtondia and Ngerenya dispensaries</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:45px;\">\n <p>\n <strong>Emergency facilities </strong></p>\n <p>\n - Access to Kilifi Level 5 County Referral Hospital with ICU.</p>\n <p style=\"margin-left:.25in;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:74px;\">\n <p>\n <strong>Other Infrastructure </strong></p>\n <ul>\n <li>\n Demographic surveillance System (DSS)</li>\n <li>\n Community Liaison Department</li>\n <li>\n Access to hospital OBS/GYN consultants and other county health staff.</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study is being conducted in the same host country as the applicant.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE.</p>\n
      • other_details_regulatory_approved<div>\n 1. The KEMRI Scientific and Ethics Review Unit</div>\n<div>\n (SERU) 23 Jan 2023.</div>\n<div>\n  </div>\n<div>\n <div>\n 2.Oxford Tropical Research Ethics Committee, 31st Jan 2023.</div>\n <p>\n  </p>\n <p>\n Approval granted for one site in Kilifi, Kenya.</p>\n</div>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n NONE.</p>\n
      • other_details_regulatory_halted<p>\n NOT APPLICABLE.</p>\n
      • estimated_duration36 MONTHS.
      • 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_comparatorUNIMMAP WITH 60 MG IRON.
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKILIFI
      • single_site_physical_addressKEMRI CENTRE FOR GEOGRAPHIC MEDICAL RESEARCH -COAST, OFF BOFA ROAD, INSIDE KILIFI COUNTY HOSPITAL COMPOUND, KILIFI.
      • single_site_contact_personDR. MARTHA MWANGOME
      • single_site_telephone0722203417
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site216
      • total_participants_worldwide216
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailMMwangome@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants216
      • notification<p>\n NONE.</p>\n
      • approval_date24-07-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-05-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer responses have been addressed adequately
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 17:04:32
      • created2023-02-08 14:05:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id899
        • application_id1225
        • given_nameDR. Martha
        • middle_nameKaeni
        • family_nameMwangome
        • qualificationPHD
        • professional_addressKILIFI WELLCOME TRUST , P.O BOX 230
        • telephone0722203417
        • emailmmwangome@kemri-wellcome.org
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
    • SiteDetail(array)
      • 0(array)
        • id1450
        • application_id1225
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id640
        • application_id1225
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personSAMI KELSH
        • addressBoundary Brook House, Churchill Drive, Oxford OX3 7LQ
        • telephone_number+44 1865 70000
        • fax_number
        • cell_number+44 1865 70000
        • email_addressresearch.services@admin.ox.ac.uk
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
  • 3(array)
    • Application(array)
      • id1188
      • user_id667
      • trial_status_id8
      • abstract_of_study<p>\n Women living with HIV face up to six times increased risk of cervical cancer, and cervical cancer is a leading cause of death in this population. Current approved treatment for high-grade cervical precancer, scientifically termed cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3), is either ablation (cryotherapy or thermal ablation) or excision. Both treatment methods are associated with high rates of CIN2/3 treatment failure in women with HIV,  up to 30% at one year. Studies in high-income countries have demonstrated that off-label use of self-administered, intravaginal 5% 5-FU cream following primary CIN2/3 treatment in HIV-positive women can reduce treatment failure. </p>\n<p>\n This is a single arm pilot study investigating the safety, uptake, tolerability, adherence, and acceptability of off-label self-administered intravaginal 5% fluorouracil (5-FU) cream as adjuvant therapy following primary treatment for CIN2/3 among women living with HIV in Kenya.  Fourteen participants will be enrolled. Participants will self-administer 2 grams of 5% 5-FU cream intravaginally biweekly (every other week, on weeks 1, 3, 5, 7, 9, 11, 13, 15) for a total of 8 applications, and will return to the clinic on weeks 2, 4, 6, 8,10, 12, 14, and 16 for safety and adherence assessments, including a pelvic exam by a trained clinician. Our hypothesis is that adjuvant, self-administered 5% 5-FU cream, used intravaginally at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. Our hypothesis is that adjuvant, intravaginal, self-administered 5% 5-FU cream at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. This trial, together with data from other studies, will support proceeding to a randomized phase II or phase III trial in Kenya to investigate whether this intervention will reduce CIN2/3 recurrence as has been demonstrated in other settings. </p>\n
      • study_title<p align=\"left\">\n UNCPM  22120: Safety of adjuvant, self-administered intravaginal 5-fluorouracil (5-FU) cream following cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) treatment among HIV-positive women in Kenya: A pilot study</p>\n
      • laymans_summary<p>\n Women living with HIV are up to six times more likely to get cervical cancer. Cervical cancer screening can identify early changes in the cervix (known as precancer), which can be treated at this early stage. Among women with HIV, the current treatment methods for cervical precancer are not completely effective. Up to 30% of women can continue to have precancer after treatment – known as treatment failure. Because of this, scientists are investigating methods to improve the current cervical precancer treatment methods for women living with HIV. Previous studies in other countries have shown that a medication known as 5-FU, which is available as cream and used to treat skin precancer or cancer, can be used intravaginally after initial cervical precancer treatment in HIV-positive women, to reduce treatment failure. </p>\n<p>\n This study seeks to investigate whether a generic, commonly available chemotherapeutic drug which available as a cream, known as Fluorouracil (5-FU), can be used off-label by women with HIV as an additional, self-administered, intravaginal treatment after the currently approved treatment methods, to reduce cervical precancer treatment failure. The study aims to investigate whether intravaginal 5FU used in this manner is safety, whether many women will want to use it (uptake & acceptability), whether side effects will be few as it has been shown in other studies (tolerability), and whether women will use the medication as instructed (adherence). <strong>This study will last approximately 20 weeks. Women who are enrolled in the study will apply the study medication (5% 5-FU cream) inside the vagina before sleeping once every other week, and they will visit the study clinic on alternative weeks to be monitored for any side effects. Women in the study will keep a calendar of when they use the medication and will write down any symptoms or side effects they have (using a symptom diary), if they are able to read and write. Additionally, all women in the study will be called weekly by a research assistant to report any symptoms they have. Any study participant with concerning symptoms will be seen by a study clinician, and all costs will be covered by the study. At the end of the study, women will be asked about their experience with using the intravaginal treatment. </strong>The information obtained from this study will be used to understand whether 5% 5FU cream can be used off-label widely by more women with HIV following precancer treatment in Kenya and the rest of Africa and the world to improve the effectiveness of current precancer treatment methods. </p>\n
      • short_titleUNCPM 22120 5-FU Study
      • protocol_noECCT/22/11/02
      • version_no1.1
      • date_of_protocol10-02-2023
      • study_drugFluorouracil 5% cream
      • disease_conditionCervical cancer
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_name5-fluorouracil
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-rctp.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_applicantGreshon Rota
      • declaration_date118-11-2022
      • declaration_principal_investigatorProf. Elizabeth Bukusi
      • declaration_date218-11-2022
      • placebo_presentNo
      • study_objectives<h2>\n <u>Primary Objective</u></h2>\n<p>\n • To evaluate the safety of 2 grams adjuvant self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment among WLWH in Kenya, used every two weeks. </p>\n<p>\n <br />\n <u>Secondary Objectives</u></p>\n<p>\n 1. To evaluate the uptake of adjuvant, self-administered, intravaginal 5% 5-FU cream following CIN2/3 among WLWH in Kenya. </p>\n<p>\n 2. To evaluate the tolerability of self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Kenya. </p>\n<p>\n 3. To evaluate adherence to self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Kenya</p>\n<p>\n 4. To evaluate acceptability of self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment among WLWH in LMICs.<br />\n  </p>\n
      • principal_inclusion_criteria<p style=\"margin-left:36.0pt;\">\n 1.      HIV-positive women (confirmed with serum antibody testing)</p>\n<p style=\"margin-left:36.0pt;\">\n 2.      Age 18 years  – 49 years at enrollment</p>\n<p style=\"margin-left:36.0pt;\">\n 3.      Documentation of a biopsy-confirmed CIN2 or CIN3 </p>\n<p style=\"margin-left:36.0pt;\">\n 4.      Within 4-12 weeks after primary treatment (either cryotherapy, thermal ablation, or loop electrosurgical excision procedure (LEEP)) for CIN2 or CIN3 _</p>\n<p style=\"margin-left:36.0pt;\">\n 5.      Negative pregnancy test at screening</p>\n<p style=\"margin-left:36.0pt;\">\n 6.      Agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation – plus condoms) during the study duration, if of childbearing age. Condoms can be male or female condoms</p>\n<p style=\"margin-left:36.0pt;\">\n 7.      Ability to understand and willingness to sign (or assent when applicable) informed consent </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:43.2pt;\">\n 1.         Unwilling or unable to use birth control during participation in the study</p>\n<p style=\"margin-left:43.2pt;\">\n 2.         History of invasive cervical cancer</p>\n<p style=\"margin-left:43.2pt;\">\n 3.         Known allergy to 5-Fluorouracil</p>\n<p style=\"margin-left:43.2pt;\">\n 4.         History of total hysterectomy</p>\n<p style=\"margin-left:43.2pt;\">\n 5.         Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient</p>\n<p style=\"margin-left:43.2pt;\">\n 6.         Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)</p>\n
      • primary_end_points<p>\n Type, frequency, and severity of AEs.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Principal Investigator and role</strong></p>\n<p>\n  </p>\n<p>\n <strong>Chemtai Mungo, MD, MPH</strong>: Dr. Chemtai Mungo will provide expertise and guidance on protocol development, subject matter expertise, oversee all aspects of protocol implementation, and lead data analysis, interpretation, dissemination of results and future Phase II grant writing and implementation.</p>\n<p>\n  </p>\n<p>\n <strong>Co-Investigators and roles </strong></p>\n<p>\n  </p>\n<p>\n <strong>Elizabeth Bukusi, MBChB, MMed, KEMRI (</strong>Principal Co-Investigator)<strong>:</strong> Dr. Bukusi will provide expertise and guidance on subject matter and protocol implementation, including ethical considerations, collaborative management, study implementation and dissemination of findings.</p>\n<p>\n  </p>\n<p>\n <strong>Lisa Rahangdale, MD, MPH, UNC</strong> (Co-Investigator)<strong>:</strong> Dr. Rahangdale will provide subject matter expertise and guidance on protocol implementation and provide guidance on data analysis, interpretation, dissemination and Phase II grant writing and future work.</p>\n<p>\n  </p>\n<p>\n <strong>Jackton Omoto, MBChB, MMed, Maseno University</strong> (Co-Investigator): Dr. Omoto will provide subject matter expertise, guidance on study design, protocol implementation, as well as support in building capacity of providers to deliver the intervention</p>\n<p>\n  </p>\n<p>\n <strong>Cirillus Ogollah, BSc, DipCM, KEMRI</strong> (Co-Investigator): Mr. Ogollah will play a critical role in managing all study field operations in Kenya and will be involved in data analysis and dissemination of results.</p>\n<p>\n  </p>\n<p>\n <strong>Gershon Rota, B Pharm, KEMRI</strong> (Co-Investigator & Study Pharmacist): Dr. Rota will participate in implementation of study medicine and reporting of adverse effects</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n <strong>Michael Hudgens, PhD; UNC (Biostatistician):</strong> Dr. Hudgens will be the lead statistician and provide expertise related to study design, power calculations, data analysis and interpretation.</p>\n
      • other_details_explanation<p>\n The study is an investigator-initiated study targeting HIV-positive women in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 weeks
      • 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_stateYes
      • location_of_areaJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
      • single_site_physical_address614-40100 Kisumu
      • single_site_contact_personCirilus Ogolla
      • single_site_telephone0724717472
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site14
      • total_participants_worldwide14
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • 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_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
      • investigator1_telephone+254733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participants14
      • notification
      • approval_date01-03-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-02-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonPI responses to the Querries have ben reviewed and 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)
      • modified2024-07-10 10:20:05
      • created2022-11-15 20:45:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id863
        • application_id1188
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
        • professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
        • telephone+254733617503
        • emailebukusi@kemri.go.ke
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
      • 1(array)
        • id864
        • application_id1188
        • given_nameChemtai
        • middle_name
        • family_nameMungo
        • qualificationMBChB, MPH
        • professional_address3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599, United States
        • telephone+1-919-966-6049
        • emailChemtai_mungo@med.unc.edu
        • created2022-11-15 21:17:01
        • modified2023-02-13 09:37:27
    • SiteDetail(array)
      • 0(array)
        • id1332
        • application_id1188
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id614
        • application_id1188
        • sponsorUniversity of North Carolina OBGYN Department
        • sponsor_typeResearch Institution
        • contact_personBenjamin Chi
        • addressCHAPEL HILL, NC 27599-7570, United States
        • telephone_number+1-919-966-5281
        • fax_number+1-919-966-6049
        • cell_number+1-919-966-5281
        • email_addressinfo@UNCobgyn.org
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
  • 4(array)
    • Application(array)
      • id1422
      • user_id263
      • trial_status_id(null)
      • abstract_of_study<p align=\"left\">\n This will be a phase III, hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled, international, multicentre, non-inferiority trial. Participating women will be randomized to receive either intravenous HSC or oxytocin as the ‘first-line’ uterotonic for PPH treatment.</p>\n<p align=\"left\">\n The trial will be conducted across 20 tertiary level hospitals within the WHO “CHAMPION” Trial Network in Argentina, Kenya, India, Nigeria, Uganda, South Africa, and United Kingdom.</p>\n<p align=\"left\">\n Care providers will inform potentially eligible pregnant women about the trial during their antenatal care visits to the hospital. If a woman is seen for the first time during her admission to the hospital for childbirth, she will be provided information about the trial then. Women will be approached for participation in the trial if she is in early labour (<6cm cervical dilatation), her vital signs are normal, and she is not distressed at the moment of giving consent. Informed consent will be obtained from the woman before any trial-related procedures are carried out.</p>\n<p align=\"left\">\n Women having a vaginal birth who have been consented in early labour will receive an intramuscular (IM) prophylactic 100 µg dose of HSC for PPH prevention. Following the birth of the baby, a calibrated drape will be placed under the woman’s buttocks to measure blood loss following birth. Should atonic PPH based on a clinical diagnosis or blood loss estimation of 500 ml or more occur, the woman will be randomized to receive a saline intravenous (IV) infusion of HSC 100 µg or oxytocin 5 IU over 5 minutes. Following this treatment, women in the oxytocin arm (active control) will receive an additional 20 IU at a lower saline infusion rate over 4 hours in line with standard clinical practice, while women in HSC arm will receive an equivalent amount of saline infusion but with no additional uterotonic for the same period. Upon randomization, a new drape will be placed under the woman’s buttocks to measure further blood loss for 90 minutes. </p>\n<p align=\"left\">\n The investigational medicinal product (IMP) will be administered immediately following randomization of trial participants. Once the IMP has been administered to the woman as described above, the clinical staff will continue further PPH management in accordance with existing hospital PPH management protocol and WHO guidelines.</p>\n<p align=\"left\">\n All women will be followed up for 24 hours after randomization or until hospital discharge, whichever is soonest.</p>\n<p>\n The trial will be implemented with an internal safety sub-study. The first interim analysis will be conducted for an independent Data Safety Monitoring Committee (DSMC) to assess comparative safety of HSC versus oxytocin once the first 250 participants have been enrolled into the trial. </p>\n
      • study_title<p align=\"left\">\n <strong>Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial</strong></p>\n
      • laymans_summary<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Title: A Phase III Trial Comparing HSC and Oxytocin for Postpartum Hemorrhage Prevention</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Objective: This international, multicenter trial aims to compare the effectiveness and safety of intravenous HSC (an investigational uterotonic) with oxytocin (the current standard) for preventing postpartum hemorrhage (PPH).</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Study Design:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Type: Hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Participants: Pregnant women at 20 tertiary level hospitals across Argentina, Kenya, India, Nigeria, Uganda, South Africa, and the United Kingdom.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Eligibility: Women in early labor with normal vital signs and no distress.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Randomization: Participants will receive either HSC or oxytocin as the first-line uterotonic.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Treatment Administration: Women having a vaginal birth will receive an intramuscular prophylactic dose of HSC. If atonic PPH occurs (500 ml blood loss or more), they will be randomized to receive either HSC or oxytocin via intravenous infusion.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Follow-up: All women will be monitored for 24 hours after randomization or until hospital discharge.</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Safety Sub-Study:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n An internal safety sub-study will assess the comparative safety of HSC versus oxytocin.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n The first interim analysis will occur after enrolling the first 250 participants.</p>\n<p lang=\"en-ZA\" style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n  </p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n This trial aims to improve PPH management and enhance maternal health outcomes.</p>\n<p style=\"padding: 0px; margin: 12px 0px 0px; word-break: break-word; font-size: 16px; line-height: var(--cib-type-body2-line-height); font-variation-settings: var(--cib-type-body2-font-variation-settings); color: rgb(17, 17, 17); font-family: -apple-system, Roboto, SegoeUI, "Segoe UI", "Helvetica Neue", Helvetica, "Microsoft YaHei", "Meiryo UI", Meiryo, "Arial Unicode MS", sans-serif; background-color: rgb(247, 247, 247);\">\n  </p>\n
      • short_titleWHO A66045
      • protocol_noECCT/24/08/04
      • version_no3.0
      • date_of_protocol03-09-2023
      • study_drugHeat-stable carbetocin (HSC)
      • disease_conditionpostpartum haemorrhage
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameHeat-stable carbetocin (HSC)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameoxytocin
      • comparator_registeredyes
      • comparator_countriesMost countries including Kenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.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_applicantDanielle Erasmus
      • declaration_date113-08-2024
      • declaration_principal_investigatorProf Zahida Qureshi
      • declaration_date213-08-2024
      • placebo_presentNo
      • study_objectives<p>\n The main aim of this trial is to generate evidence on the efficacy and safety of HSC compared to oxytocin when used as ‘first-line’ uterotonic for PPH treatment.</p>\n<p>\n The <strong>primary objective</strong> of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization.</p>\n<p>\n There are two hypotheses for the primary objective (one non-inferiority and one superiority hypotheses):</p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:601px;height:68px;\">\n <ol>\n <li>\n Intravenous (IV) HSC is non-inferior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more within a non-inferiority margin of 4% risk difference scale (primary hypothesis).</li>\n <li>\n Intravenous (IV) HSC is superior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more (secondary hypothesis). </li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n The <strong>secondary objectives</strong> are to (i) evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; and (ii) evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Trial participants will be women who receive HSC for PPH prophylaxis and are diagnosed with PPH presumed to be due to uterine atony after a vaginal birth.</p>\n<p>\n To be eligible for inclusion into this trial, the women must fulfil <strong><u>all</u></strong> the following criteria:</p>\n<ul>\n <li>\n had a singleton pregnancy</li>\n <li>\n had a vaginal birth</li>\n <li>\n receive HSC (IM) for PPH prophylaxis</li>\n</ul>\n<ul>\n <li align=\"left\">\n have an indication to receive uterotonics for the treatment of PPH presumed due to uterine atony (clinically diagnosed, or measured vaginal blood loss of 500 ml or more in the first 60 minutes postpartum) and where known coagulopathy and retained placenta has been excluded as the cause of bleeding)</li>\n</ul>\n<ul>\n <li>\n provide written informed consent before any trial-related procedures are carried out</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Women are not eligible for this trial if they fulfill <strong><u>any</u></strong> of the following exclusion criteria:</p>\n<ul>\n <li align=\"left\">\n known history of allergy to oxytocin or HSC or any of their excipients.</li>\n <li align=\"left\">\n known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease.</li>\n <li align=\"left\">\n known intrauterine fetal death.</li>\n <li align=\"left\">\n birth that is considered an abortion according to local gestational age limit.</li>\n <li align=\"left\">\n have other clinically significant condition(s) that, in the opinion of the investigator could represent increased risk for the participation of the woman or interfere with the objectives of the study.</li>\n <li align=\"left\">\n a manual removal of placenta.</li>\n <li align=\"left\">\n a placenta in situ that has not been expelled or removed.</li>\n <li align=\"left\">\n known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<h3>\n Primary end-points</h3>\n<p>\n The primary end-point is the proportion of women with additional vaginal blood loss of ≥ 500 ml at 90 minutes following randomization.</p>\n<p>\n <strong>Key Secondary end-points</strong></p>\n<ul>\n <li>\n The proportion of women with additional blood loss of ≥1000 ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics at 90 minutes following randomization</li>\n <li>\n The proportion of women with additional blood loss of ≥ 500 ml or receiving additional uterotonic(s) at 90 minutes following randomization</li>\n <li>\n The proportion of women having surgical procedures related to PPH (e.g. laparotomy for compressive sutures, artery ligation or hysterectomy, or uterine balloon tamponade) as at 24 hours following randomization.</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment up to 24 hours.  </li>\n</ul>\n<p>\n <strong>Other secondary end-points</strong></p>\n<ul>\n <li>\n Amount of blood loss in ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics as at 24 hours following randomization</li>\n <li>\n The proportion of women receiving blood transfusion products up to 24 hours following randomization</li>\n <li>\n The proportion of women admitted to intensive care unit as at 24 hours following randomization</li>\n <li>\n The proportion of maternal deaths</li>\n <li>\n The proportion of women with clinically defined coagulopathy as documented in medical records as at 24 hours following randomization</li>\n <li>\n The proportion of women breastfeeding as at 24 hours following randomization</li>\n</ul>\n<ul>\n <li>\n The proportion of women hypovolemic shock up to 24 hours following randomization</li>\n <li>\n The proportion and severity of adverse or serious adverse events up to 24 hours following randomization</li>\n <li>\n The proportion of women with composite outcome of maternal death or severe morbidity as at 24 hours following randomization into trial</li>\n</ul>\n<ul>\n <li>\n The proportion of women with any haemodynamic change requiring therapeutic intervention during the first 10 minutes of administering treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment in the first 10 minutes after initiating treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which results in cardiac arrest during the first 24 hours following randomization</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n 1. Qureshi Zahida, MBChB, Mmed Ob/Gyn</div>\n<div>\n Associate Professor of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi, Department of Obstetrics and Gynaecology</div>\n<div>\n P.O Box 19676-00202 KNH, Nairobi Kenya 0733605410</div>\n<div>\n zahida@qureshi.co.ke</div>\n<div>\n Principal Investigator: Responsible for the development and overall project oversight, science and overseeing all implementing team members in Kenya</div>\n<div>\n  </div>\n<div>\n 2. Osoti Alfred. MBChB, Mmed (Ob/Gyn), MPH, PHD</div>\n<div>\n Associate Professor, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 2343 00202 KNH Nairobi 0733886664</div>\n<div>\n alfredos@uw.edu</div>\n<div>\n Co-Investigator: Responsible for Human Resource, monitoring and evaluation and quality control during data collection period</div>\n<div>\n  </div>\n<div>\n 3. Gwako George. MBChB, Mmed (Ob/Gyn), PHD</div>\n<div>\n Lecturer, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 4848-00200 Nairobi 0722992268</div>\n<div>\n gngwako@gmail.com</div>\n<div>\n Co-Investigator: Responsible for guiding study design, implementation and analysis</div>\n<div>\n  </div>\n<div>\n We are ideally suited to work with the Ministry of Health, County level 5 Hospitals. We have identified 3 sites that will serve as potential sites for this trial. These are;</div>\n<div>\n  </div>\n<div>\n Machakos County Referral Hospital – Lead Obstetrician Gynecologist Dr. Alice Isika</div>\n<div>\n Kiambu Level 5 Hospital – Lead Obstetrician Gynecologist Dr. Mary Maina</div>\n<div>\n Pumwani maternity Hospital – Lead Obstetrician Gynecologist Dr. Mandi Sura</div>\n<p>\n <strong>Machakos Level 5 Hospital</strong> is a public referral hospital located in Machakos County. It handles over 500 deliveries per month. The hospital offers a variety of services for outpatients (General Care, Dental Services, Pharmacy Services, Laboratory Services, Imaging Services, HIV/AIDS Prevention Treatment and Care, Maternal and Child Health, Eye Services, Nutrition Services) as well as inpatients (Medical ward/Surgical ward, Maternity Ward, Post Natal Ward, New Born Unit, Pediatric Ward, Operating Theatre, Inpatient gynaecology consultation, Physiotherapy). The hospital provides ANC to approximately 200 women each month. It has a 507-bed capacity with 57 newborn cots. There are 2 consultant obstetricians/gynaecologists, and 4 Medical Officers. It has an average of 350 deliveries in a month. The hospital has established referral networks with emergency transport availability.</p>\n<p>\n During the trial, skilled and adequately GCP trained individuals will be involved in the trial management. When the woman attends the delivery suite, a skilled health personnel in charge of caring women in labor at the hospital will provide sufficient information about the trial and, will request consent from the participant. Following birth of the baby, screening of the consented participants will be undertaken to ensure eligibility by a skilled and trained, member of research team. Eligibly participants will be randomized and  the member of the research team will conduct ongoing data collection safely and effectively.</p>\n<div>\n <strong>Kiambu Level 5 Hospital </strong>is a public health facility situated in Kiambu County. It serves a large population both urban and rural. The hospital serves as the referral center for catchment areas from nearby sub counties.. It has 45 beds dedicated to the maternity unit. The hospital provides Antenatal services to approximately 260 women per month. It has 2 Obstetrician gynaecologists, 3 Medical officers and 27 midwives. It handles approximately 700 deliveries per month. The preterm birth (<34 weeks) rate Is 7%. The preterm mortality rate is 45%. About 34% pregnant mothers are registered to ANC before 12 weeks of gestation.</div>\n<div>\n Available services include ultrasonography, tocolytic drugs, antenatal corticosteroids, caesarean sections and instrumental deliveries- Vacuum deliveries. It has a 46 bed capacity maternity ward with 22 midwives, 4 medical officers and 5 Obstetrician/Gynaecologists. There is piped oxygen and a 2 bed adult ICU, where a 3rd bed is created for Obstetric patients. The new born unit is a 50 bed capacity with 11 nurses and 4 paeditricians. There is no NICU. Basic resuscitation services are available including incubators, radiant heaters and piped oxygen. CPAP is available, however exogenous surfactant is not available.</div>\n<div>\n  </div>\n<div>\n <div>\n <strong>Pumwani Maternity Hospital </strong>is the largest maternity hospital situated in Nairobi County. The facility is managed by the County Government of Nairobi. It serves as the major referral centre for the county and beyond. The hospital provides comprehensive emergency obstetric and newborn care and has ultrasound services.</div>\n <div>\n The facility has 354 obstetrics bed capacity, 144 baby cots and 2 operating theatres. There are 4 Obstetrician gynaecologists, 4 Medical Officers and 25 Midwives. Average number of deliveries per month is 1000 with approximately 70-100 per day. The facility has well equipped laboratory and functional blood transfusion services.</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Sites that participated in the CHAMPION study and are part of the WHO CHAMPION Trial network will participate in this study. If licensed, HSC would have most benefit in settings where temperature control uterotonics cannot be guaranteed. Switzerland would not meet these criteria. That said, as a representative of a HIC we have selected the UK to ensure the diversity of settings. The trial site in the UK previously participated in the CHAMPION Trial and has local expertise in PPH treatment trials.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n South Africa: SAHPRA approval dated 22 Jan 2024- 2 Sites</p>\n<p>\n  </p>\n<p>\n UK – MHRA approval date 05Mar2024 – 1 site</p>\n<p>\n  </p>\n<p>\n ARG – ANMAT approval date 30 May 2024 – 2 sites</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration54 months according to the following schedules: 12 months for trial preparation; 30 months for trial enrolment; and 12 months for final analysis, trial publication and dissemination of results.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyActive controlled, non-inferiority trial
      • design_controlled_comparatorOxytocin
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • 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_states7
      • number_of_sites3
      • multi_country_listArgentina, India, Kenya, Nigeria, South Africa, Uganda, and United Kingdom
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMachakos county hospital: we estimate around 393 women could be randomized across 30 months. \nPumwani maternity hospital: we estimate around 301 women could be randomized across 30 months\nKiambu level five hospital: we estimate around 376 women could be randomized across 30 months.
      • total_participants_worldwide6200
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationMBBS, Mmed, Ob/Gyn
      • investigator1_professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
      • investigator1_telephone+254 733 605 410
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participants1000
      • notification
      • approval_date06-02-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-08-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer queries 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)
      • modified2025-02-06 12:45:38
      • created2024-06-18 16:21:02
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1079
        • application_id1422
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationMBBS, Mmed, Ob/Gyn
        • professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
        • telephone+254 733 605 410
        • emailzahida@qureshi.co.ke
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
    • SiteDetail(array)
      • 0(array)
        • id1725
        • application_id1422
        • county_id16
        • site_name Machakos county hospital
        • physical_addressP.O Box 19-90100 Machakos
        • contact_details+254721404445
        • contact_personDr. Alice Isika
        • site_capacity(null)
        • misc(null)
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 1(array)
        • id1726
        • application_id1422
        • county_id47
        • site_namePumwani maternity hospital
        • physical_addressP. O Box 42849-00100 Nairobi
        • contact_details+254722775150
        • contact_personDr. Mandeep Sura
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:07:14
        • modified2024-08-16 14:40:55
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1727
        • application_id1422
        • county_id22
        • site_nameKiambu level 5 hospital
        • physical_addressP.O Box 39-00900 Kiambu
        • contact_details +254722327304
        • contact_personDr. Mary Maina
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:08:29
        • modified2024-08-16 14:40:55
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id755
        • application_id1422
        • sponsorWHO
        • sponsor_typeIndustry
        • contact_personMariana Widmer
        • addressAvenue Appia 20 1211 Geneva 27 Switzerland
        • telephone_number+41227914323
        • fax_number
        • cell_number+41227914323
        • email_addresswidmerm@who.int
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 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/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php