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• trial_statuses(array)
  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id789
      • user_id522
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background</strong>: Induction of labor (IOL) has increasingly become a common procedure, more so in developed countries where the incidence currently averages 20-30%. In developing countries, IOL is variable ranging from 2% to as high as that seen in developed nations. In MTRH, about 5% of all deliveries are term inductions. Nulliparous women often comprise over half of those requiring IOL even in our setting. Additionally, the presence of an unfavorable cervix prior to induction is not uncommon in this group and is often associated with failed inductions, labor dystocia, caesarean sections and longer hospital stays. Hence the need for preinduction cervical ripening using a safe, efficient and cost effective method. This optimal method is not known. Recently, the concurrent use of Foley catheter (FC) with oxytocin for cervical ripening has been studied albeit in primarily Caucasian population. The findings have nonetheless been mixed.</p>\n<p>\n <strong>Objective</strong>: To determine whether adding low dose oxytocin to preinduction cervical ripening with a FC affects the time to delivery, proportion of deliveries within 24 hours and fetomaternal outcomes in nulliparous women at MTRH.</p>\n<p>\n <strong>Methods</strong>: This is a randomized double blind placebo controlled trial to be conducted at the Riley Mother and Baby hospital in MTRH. 220 nulliparous women aged at least 18 years with a single, live, vertex pregnancy and scheduled for IOL with an unfavorable cervix at or beyond 34 weeks gestation will be systematically sampled for inclusion in the study. Consenting participants will be allocated to receive FC plus low dose oxytocin or FC plus placebo using block randomisation, with a block size of 20. The primary and secondary endpoints will be at delivery and 24 hours post-delivery respectively. Data will be collected using semi-structured data collection forms and entered into an electronic database using Microsoft Access. Categorical variables will be summarized using frequencies and percentages. Continuous variables will be summarized using mean and the corresponding standard deviation (SD) if the Gaussian assumptions hold or using median and the corresponding inter quartile range (IQR) if the Gaussian assumptions are violated. The time to delivery will be compared between the two arms using independent t-test if the Gaussian assumptions hold or using the two sample Wilcoxon rank-sum test if the Gaussian assumptions are violated. Categorical variables will be compared between the two arms using Pearson’s Chi Square test. Linear regression model will be used to assess the effect of Foley catheter plus oxytocin adjusting for potential confounding variables. We shall report the regression coefficients and the corresponding 95% confidence intervals. Results will be presented using tables and graphs. Data analysis will be done using SAS version 9.4.</p>\n<p>\n <strong>Expected findings:</strong> The time to delivery has a potentially significant impact on resources and obstetric outcomes. Our study seeks to establish the impact of concurrent FC and oxytocin on the time to delivery and the safety of the same in nulliparous women undergoing cervical ripening in our setting. This will robustly complement previous studies and ultimately inform future protocols with rational, objective and evidence based data.</p>\n
      • study_title<p>\n LOW DOSE OXYTOCIN AS AN ADJUNCT TO FOLEY CATHETER FOR CERVICAL RIPENING IN NULLIPAROUS WOMEN AT MTRH, ELDORET, KENYA: A RANDOMISED CONTROLLED TRIAL.</p>\n
      • laymans_summary(null)
      • short_titleLOxaF- N Trial
      • protocol_noECCT/19/08/02
      • version_no1
      • date_of_protocol26-09-2018
      • study_drugOxytocin
      • disease_conditionRipening of the cervix
      • 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_nameSyntocinon
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspatrickomondi_md@yahoo.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPatrick Omondi Otieno
      • declaration_date123-06-2019
      • declaration_principal_investigatorDr Patrick Omondi
      • declaration_date223-06-2019
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n a. Nulliparous women at or beyond 34+0 weeks gestation from the LMP b. At least 18 years old c. Single, live and vertex fetus d. Written informed consent</p>\n
      • principal_exclusion_criteria<p>\n a. Admission Bishop score > 6</p>\n<p>\n b. Sonographically confirmed anomalous fetus.</p>\n<p>\n c. Prelabor rupture of membranes (PROM)</p>\n<p>\n d. Suspected intraamniotic infection</p>\n<p>\n e. Intrauterine fetal demise</p>\n<p>\n f. Any contraindication to vaginal delivery</p>\n<p>\n g. Scarred uterus</p>\n
      • primary_end_points<p>\n Delivery of the fetus.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n MTRH is a level 6 tertiary referral health facility in Eldoret, Uasin Gishu county. The RMBH has 4 wards namely; antenatal ward (ANW), postnatal ward (PNW) and labor ward (L/W) where women in active phase of labor are admitted for monitoring and delivery. The RMBH unit is staffed by about 16 consultant obstetrician/gynecologists from both Moi University and MTRH, 46 residents/registrars and 88 nurses/midwives.</p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n The Moi University/MTRH Institutional research and ethics commitee - 26/09/2018</p>\n<p>\n The Moi Teaching and Referral Hospital - 02/10/2018</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo (Water for inject
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThe Riley Mother and Baby Hospital (RMBH) at Moi Teaching and Referral Hospital (MTRH) in Eldoret, Kenya.
      • single_site_physical_address-
      • single_site_contact_personPatrick Omondi Otieno
      • single_site_telephone0731226249
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNot applicable
      • total_participants_worldwideNot Applicable
      • 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_patientsYes
      • 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_nameOtieno
      • investigator1_middle_nameOmondi
      • investigator1_family_namePatrick
      • investigator1_qualificationBachelor of Medicine and Bachelor of Surgery (MBchB)
      • investigator1_professional_address4606-30101, Eldoret, Uasin Gishu County, Kenya.
      • investigator1_telephone+254731226249
      • investigator1_emaildoc_omondi@yahoo.com
      • organisations_transferred_No
      • number_participants220 at Single study site
      • notification<p>\n N/A</p>\n
      • approval_date01-10-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-08-2019
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-11-09 18:21:07
      • created2019-04-16 13:31:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id492
        • application_id789
        • given_namePatrick Omondi
        • middle_name
        • family_nameOtieno
        • qualificationMBChB
        • professional_address4606-30100
        • telephone0731226249
        • emaildoc_omondi@yahoo.com
        • created2019-04-16 13:55:47
        • modified2019-08-25 21:19:15
    • SiteDetail(array)
      • 0(array)
        • id637
        • application_id789
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-04-16 13:55:47
        • modified2019-08-25 21:19:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id384
        • application_id789
        • sponsorSelf
        • sponsor_type(null)
        • contact_personPatrick Omondi Otieno
        • address4606-30100
        • telephone_number0731226249
        • fax_number
        • cell_number0731226249
        • email_addressdoc_omondi@yahoo.com
        • created2019-04-16 13:55:47
        • modified2019-08-25 21:19:15
  • 1(array)
    • Application(array)
      • id778
      • user_id81
      • trial_status_id6
      • abstract_of_study<p>\n In July 2016, the demand for yellow fever (YF) vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through Africa and to Asia was larger than the available global supply. In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional doses of YF vaccine as a dose-sparing strategy. These recommendations were based on data from a limited number of clinical trials, none of which had been conducted in Africa. Additional studies were initiated to assess the applicability of fractional doses to all four WHO-prequalified YF vaccines with respect to vaccine immunogenicity in adults and children in Africa, including HIV positive adults. One such study, comparing full standard dose to 1/5^th of standard dose of all four WHO-prequalified YF vaccines in adults (Clinicaltrials.gov number: NCT02991495), is currently ongoing at KEMRI CGMRC (see SERU protocol 3452) and Epicentre, Mbarara (UNCST HS 2237) and is designed to answer questions on the use of current stock of YF vaccines with a potency as close as possible to each manufacturers’ minimum release. Data from this trial will inform a WHO recommendation on using 1/5^th of the current standard dose of vaccine for outbreak control.  However, since many vials will contain excess YF vaccine such that 1/5^th of a vial is likely to be substantially above the current minimum potency requirements, these data may not be scientifically explanatory regarding the minimum dose required for preventive use.</p>\n<address>\n Here, in this new complementary study, we aim to determine the lowest YF vaccine dose that is non-inferior to the current standard full dose among populations in sub-Saharan Africa. The study will be conducted in Kenya (KEMRI CGMRC, Kilifi) and Uganda (Epicentre, Mbarara) with trial participants recruited at both sites, using vaccine from one WHO-prequalified manufacturer (Institut Pasteur de Dakar, Senegal). Our primary aim is to compare the immunogenicity of full standard dose of vaccine with three lower doses in adults, using seroconversion at 28 days post-vaccination, measured by plaque reduction neutralization assay (PRNT₅₀), as the endpoint. Adult participants (n=480) will be randomized for vaccination with full standard dose or with approximately 1000, 500 or 250 IU of vaccine (i.e. 4 arms, 1:1:1:1 allocation ratio). Safety and immunogenicity results will then be reviewed by the study DSMB, and the lowest non-inferior dose selected for assessment in a sub-study in children (n=420) in comparison to full standard dose (i.e. 2 arms, 1:1 allocation ratio). Secondary objectives will include immunogenicity at 10 days, 1 year and 2 years post-vaccination, assessment of the influence of cross-reactive antibodies to other flaviviruses on vaccine immunogenicity, assessment of T and B cell immune responses, assessment of virological and immunological kinetics and occurrence of serious adverse events (SAE). In addition, we will assess the range of views and perceptions of key stakeholders in vaccine policy and implementation on lower vaccine dose usage during YF epidemics and routine use. We expect the data from this qualitative study to inform the implementation of policies relating to low-dose vaccine usage for the control of YF and other diseases (e.g. pneumococcal vaccines) where such strategies are in consideration.</address>\n<p>\n  </p>\n
      • study_title<address>\n <p>\n <em>Non-Inferiority Fractional-Doses Trial For Yellow Fever Vaccine</em></p>\n <p>\n  </p>\n</address>\n
      • laymans_summary<p>\n Lay Title: A trial to determine the safety and immune response elicited by the reduced doses of yellow fever vaccine in comparison to full dose of the vaccine in Kenyan and Ugandan adults and children What is the problem/background? Yellow fever (YF) is a disease caused by a mosquito-borne flavivirus that is endemic in sub-Saharan Africa and tropical South America. YF virus infection can cause mild or severe illness, leading to jaundice, kidney failure, bleeding and death. The YF vaccine is shown to be very effective for disease control, including prevention of YF outbreaks. However insufficient vaccine is produced for routine use, and whilst a YF vaccine stockpile is reserved for outbreak control, this is frequently depleted. Measures to increase the global supply of YF vaccine are urgently needed. What questions are we trying to answer? The World Health Organization (WHO) has recommended consideration of using fractions of standard YF vaccine dose to be able to vaccinate more individuals with a given quantity of vaccine in outbreak situations when there are insufficient doses to vaccinate the population at risk. However, the actual minimal dose of YF vaccine needed to elicit an immune response has not been determined. In this study, we will assess whether the immune response and adverse events occurring after vaccination of adults and children with the standard full dose of YF vaccine are comparable to those observed after vaccination with one of three lower doses of vaccine aiming to establish a minimal dose. Further, to support the implementation of a future YF control strategy using lower doses of vaccine, we will evaluate the views and perceptions of different stakeholders involved in national or international vaccine policy regarding the use of lower doses of the YF vaccine. Where is the study taking place, how many people does it involve and how are they selected? The vaccination study will take place in Kilifi, Kenya and Mbarara, Uganda among healthy adults and children who have previously not had the YF vaccine and/or YF infection and have no contraindications for vaccination. In total, 480 adults (240 at each site) and 420 children aged 9 months to 5 years (210 at each site) will be included. To evaluate views and perceptions on the use of fractional YF vaccine doses we will approach and conduct discussions and interviews with various stakeholders in national vaccine policy in Kenya, Uganda, Senegal and other international institutions. What does the study involve for those who are in it? Participants who have previously not had the YF vaccine and/or YF infection will be screened for any significant health problems. Those found eligible to participate will then be randomized to receive a single dose of the standard full dose of YF vaccine (group 1) or any of the three lower doses (groups 2 to 4). Participants will then be required to attend follow up visits to have blood taken for tests to measure immune response to vaccination, the level YF vaccine in the body, and to be asked about any side effects. Vaccine policy stakeholders included in the study will be requested to participate in interviews at their convenience. What are the benefits and risks/costs of the study for those involved? The risks relate to the possibility of developing an allergic or other reaction upon administration of the YF vaccine. Serious adverse reactions to the vaccine are, however, rare. There are no immediate health benefits to individuals participating in this study other than information about their health. If there was a YF outbreak in the future, participants getting the full YF vaccine dose would be expected to be protected and there is a chance that participants who receive the lower dose would be protected against infection. We are not able to issue YF vaccination certificates to participants at the point of vaccination. If the participant travels to endemic areas and needs a YF vaccination certificate for proof of vaccination, they will be advised to be revaccinated at an authorized health facility in Kenya or Uganda, respectively. However, on completion of the study we will offer participants the possibility to receive a YF vaccination certificate. No safety concerns are reported with multiple doses of the vaccine. The vaccine policy stakeholders participating in the study will not be at any risk associated with the vaccine trial. Any costs they incur during the process of the study will be reimbursed as out of pocket expenses. How will the study benefit society? If any of the lower YF vaccine doses safely elicits immune response that are comparable to the full vaccine dose, then in effect this finding could have an impact on the number of doses that are produced, and substantially increase the number of doses that can be given based on the world’s currently available vaccine stock, and thereby enhance our ability to prevent and control YF outbreaks. The results from the interviews and discussions with vaccine policy stakeholders will support the development of a strategy to implement the use of lower YF vaccine doses for disease control. When does the study start and finish? The study will start upon receipt of ethical approval and will be completed 40 months later.</p>\n
      • short_titleNIFTY
      • protocol_noECCT/19/03/04
      • version_noVersion 1.3
      • date_of_protocol04-03-2019
      • study_drugYellow Fever Vaccine
      • disease_conditionYellow fever
      • 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
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@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_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • 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_applicantDerick Kimathi
      • declaration_date119-03-2019
      • declaration_principal_investigatorGeorge Warimwe
      • declaration_date219-03-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary objective To determine the lowest dose (1000, 500 and 250 IU/dose) of YF vaccine that is non-inferior to the full standard dose as measured by seroconversion using the PRNT50 assay at 28 days post-vaccination in an adult population. Secondary objective(s) • To describe the geometric mean PRNT50 titre (GMT) at 10 days, 28 days, 1 year and at 2 years post-vaccination of the different doses of the YF vaccine. • To describe the change in PRNT50 titre (i.e. the geometric mean fold increase (GMFI) as a continuous variable) between baseline and day 28 after vaccination with the different doses of the YF vaccine. • To map out key stakeholders’ priorities and perceptions regarding a change in policy towards the use of fractional doses of YF vaccine and their potential influence on policy process. • To measure neutralising antibody to other flaviviruses (including dengue, West Nile and zika viruses) on the baseline sample and determine the impact of these antibodies on YF vaccine immunogenicity. • To assess post-vaccination control of viremia by vaccine dose on samples collected at baseline, and on days 2, 3, 4, 5, 6, 7 and 10 after vaccination. • To determine the change in T and B cell immune responses between baseline and days 10 and 28 post-vaccination. • To determine the change in serum cytokine and chemokine levels between baseline and days 2, 3, 4, 5, 6, 7, 10 and 28 post-vaccination • To assess the occurrence of adverse events (AE) over 28 days after vaccination and serious adverse events throughout the duration of the study.</p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Individuals aged ≥18 - <60 years of age.\n <ul>\n <li>\n For the sub-study, children aged between 9 months and 5 years.  </li>\n </ul>\n </li>\n <li>\n HIV status</li>\n <li>\n HIV negative on serological screening OR</li>\n <li>\n HIV positive adults and children aged > 18 months on serological testing, and no symptoms suggestive of current clinical immunosuppression and CD 4 count>200 (for adults) and CD4% > 25% (for children aged <5 years) within the last 6 months.</li>\n <li>\n Ability to provide informed consent to participate in the study</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Known contraindications to YF vaccination such as allergies to egg protein and chicken products or any component of the vaccine (including gelatin, eggs, eggs products or chicken products), immunodeficiency, known thymus disorder, such as thymoma and myasthenia gravis</li>\n</ul>\n<ul>\n <li>\n Using corticosteroids or other immunosuppressive therapy</li>\n <li>\n Thymus disorder, such as thymoma and myasthenia gravis</li>\n <li>\n Acute febrile disease on the day of vaccination with temperature >37.5 degrees Celsius is a temporal contraindication.</li>\n <li>\n Previous YF vaccination</li>\n <li>\n Previous YF infection as determined from history</li>\n <li>\n Pregnancy (as determined by a urine test on the proposed day of vaccination) and lactating women</li>\n <li>\n Planning to migrate out of the study areas before the end of the study follow-up</li>\n <li>\n Planning to travel to a country requiring YF vaccination certificate within the first year after vaccination.</li>\n <li>\n Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the volunteer or interfere with the outcome of the study.  </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To determine the lowest dose (1000, 500 and 250 IU/dose) of YF vaccine that is non-inferior to the full standard dose as measured by seroconversion using the PRNT₅₀ assay at 28 days post-vaccination in an adult population.</p>\n<p>\n  </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_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kilifi Capacity – 15 Staff</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<ol>\n <li>\n George Warimwe – Principal Investigator</li>\n <li>\n Derick Kimathi – Co PI</li>\n <li>\n Philip Bejon – Sponsor Representative</li>\n <li>\n Sassy Molyneux - Qualitative study, design, analysis, interpretation of results and publication.</li>\n <li>\n Mainga Hamaluba - Head of Clinical Trials facility, data quality control, assurance and analysis, interpretation of results and publication.</li>\n <li>\n Henry Karanja - Sample preparation and storage, lab assays and analysis, interpretation of results and publication.</li>\n <li>\n John Gitonga - Sample preparation and storage, lab assays and analysis, interpretation of results and publication.</li>\n <li>\n Marianne Munene - Regulatory affairs contact</li>\n <li>\n Jackline Wafula – Project Management</li>\n <li>\n Jimmy Shangalla - Pharmacist</li>\n <li>\n Naomi Kamau – Trial Nurse</li>\n <li>\n Jane Mwendwa – Trial Nurse</li>\n <li>\n Kenneth Kiogora - Trial Clinician</li>\n <li>\n Felix Moki – Trial Clinician</li>\n <li>\n Stanley Cheruiyot – Data Management</li>\n</ol>\n<p>\n  </p>\n<p>\n Uganda – Mbarara Site</p>\n<p>\n  </p>\n<p>\n Patrick Kazooba – PI for Mbarara Site</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Yellow fever (YF) is a disease caused by a mosquito-borne flavivirus that is endemic in sub-Saharan Africa and tropical South America. Ninety percent of YF cases are in Africa</p>\n
      • other_details_regulatory_notapproved<p>\n In Uganda the protocol will be submitted to Mbarara University of Science and Technology Research Ethics Committee (MUST-REC). The protocol will also be submitted to the national body, Uganda National Council for Science and Technology (UNCST) as well as the regulator body, National Drug Authority (NDA).</p>\n
      • other_details_regulatory_approved<p>\n Approval from NDA has not yet been received. The trial will be conducted in one site in Uganda</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration40 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_comparatorFull dose of yellow fever
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Kilifi
      • single_site_physical_addressIAVI Clinic
      • single_site_contact_personDerick Kimathi
      • single_site_telephone0727161778
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesTwo
      • number_of_sites
      • multi_country_listKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_site450 Kilifi\n
      • total_participants_worldwide900
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren between 9 months and 5 years, parental consent will be obtained
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameGeorge
      • investigator1_middle_name
      • investigator1_family_nameWarimwe
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O Box 230, Kilifi 80108, Kenya
      • investigator1_telephone+254 708257982
      • investigator1_emailGWarimwe@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants450 (240 adults, 210 children)
      • notification<p>\n None</p>\n
      • approval_date21-06-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-10-19 15:46:19
      • created2019-03-18 16:08:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id486
        • application_id778
        • given_nameGeorge
        • middle_name
        • family_nameWarimwe
        • qualificationPhD
        • professional_addressP.O Box 230, Kilifi 80108, Kenya
        • telephone+254 708257982
        • emailGWarimwe@kemri-wellcome.org
        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
    • SiteDetail(array)
      • 0(array)
        • id632
        • application_id778
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id379
        • application_id778
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personPhilip Bejon
        • addressP.O Box 230, Kilifi 80108, Kenya
        • telephone_number+254 724445743
        • fax_number
        • cell_number+254 724445743
        • email_addressPBejon@kemri-wellcome.org
        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
  • 2(array)
    • Application(array)
      • id770
      • user_id32
      • trial_status_id6
      • abstract_of_study<p>\n The reduction of global malaria burden over the last 15 years has been attributed mainly to the rapid scale-up of key interventions including long-lasting insecticidal nets (LLINs), indoor residual spraying (IRS) and prompt diagnosis and treatment with effective artemisinin-based combination therapies (ACTs). However, these gains are fragile and are threatened by emergence of parasite resistance to antimalarial drugs and vector resistance to insecticides. Additional tools are urgently needed to complement the current interventions. Historically, vaccines have been proven to be one of the most cost-effective means of preventing infectious diseases and saving lives. Therefore, a malaria vaccine could be an important additional tool that could complement the existing malaria control strategies. GlaxoSmithKline (GSK) Biologicals has developed a pre-erythrocytic Plasmodium falciparum malaria vaccine, RTS,S/AS01E, for protecting children against malaria in endemic areas of sub-Saharan Africa. In a large Phase III trial in young African children, the vaccine was shown to prevent malaria with a moderate level of efficacy. The vaccine received positive scientific opinion from the European Medicines Agency (EMA) and in October 2015, the World Health Organization (WHO) recommended pilot implementation of the vaccine in children 5–17 months of age, in parts of 3-5 sub-Saharan African countries to; 1) assess the programmatic feasibility of delivering the vaccine in a four-dose schedule, 2) evaluate vaccine impact on mortality and 3) further characterize vaccine safety in the context of routine immunization program. The pilot implementation will be coordinated by WHO in collaboration with the Ministry of Health and Program for Appropriate Technology in Health (PATH). As part of the pilot implementation, GSK will conduct post-approval Phase IV studies to evaluate the safety of the vaccine by monitoring for rare adverse events (AEs) such as protocol defined adverse events of special interest (AESI), other AEs leading to hospitalization or death, meningitis as well as the vaccine impact and effectiveness in vaccinated and unvaccinated cohorts.</p>\n
      • study_title<div>\n A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa (v1.0 11Oct2017): Site-specific protocol for Siaya County, western Kenya</div>\n
      • laymans_summary<p>\n The burden of malaria in the world has reduced over the last 15 years. This reduction has been attributed mainly to the rapid increase of key malaria control interventions including long-lasting mosquito nets that contain insecticides, spraying houses with insecticides and quick detection and treatment of malaria cases with drugs that work well. However, these gains are delicate and are threatened by parasites that are not killed by the drugs for malaria and mosquitos that are not killed by insecticides. Additional methods are urgently needed to add on to the current ones that are used to control malaria. In the past, vaccines have been shown to be one of the most affordable means of preventing diseases that are spread from one person to another and saving lives. Therefore, a malaria vaccine could be an important additional tool that could help the existing malaria control methods. GlaxoSmithKline (GSK) Biologicals has developed a malaria vaccine, RTS,S/AS01E or Mosquirix®, for protecting children against malaria in areas of sub-Saharan Africa where malaria is common. In a large study in young children in Africa, the vaccine was shown to prevent malaria to a certain extent, by reducing the number of times a child gets malaria, but not prevent it completely. The vaccine was assessed by the European Medicines Agency (EMA) and found to be useful. In October 2015, the World Health Organization (WHO) recommended that the vaccine be introduced and given to children 5–17 months of age, in parts of 3-5 sub-Saharan African countries in order to: 1) assess how easy it is to give the vaccine in a plan that includes a fourth does, 2) evaluate whether the vaccine reduces childhood deaths and 3) further check vaccine safety in the context of routine vaccination programs. The introduction of the vaccine called pilot implementation will be coordinated by the World Health Organization (WHO) in collaboration with the Ministry of Health and Program for Appropriate Technology in Health (PATH). As part of the pilot implementation, GSK will conduct studies which are typically done after a vaccine has been approved, to evaluate the safety of the vaccine by monitoring for adverse events (AEs) such as protocol-defined AEs of special interest (AESI), other AEs leading to hospitalization or death, meningitis as well as how well the vaccine will reduce the burden of malaria in vaccinated children compared to unvaccinated groups of children.</p>\n
      • short_titleEPI-MAL-003 (Siaya)
      • protocol_noECCT/19/03/05
      • version_no1.0
      • date_of_protocol10-10-2018
      • study_drugNone: EPI-003 Surveillance for Malaria Vaccine (RTS,S, AS01E)
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • 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_applicantDr Tony Sang - Pharmacist
      • declaration_date128-03-2019
      • declaration_principal_investigatorDr Simon Kariuki - PI
      • declaration_date228-03-2019
      • placebo_presentNo
      • study_objectives<div>\n <strong>a) The co-primary objectives are;</strong></div>\n<ol>\n <li>\n To estimate the incidence of AESI, and of other AEs leading to hospitalization or death, in children vaccinated with RTS,S/AS01E.</li>\n <li>\n To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E.</li>\n</ol>\n<div>\n <strong>b) The specific objectives to assess vaccine safety are;</strong></div>\n<ol>\n <li>\n To estimate the incidence of aetiology-confirmed and/or probable meningitis (final classification).</li>\n <li>\n To estimate the incidence of probable meningitis (final classification).</li>\n <li>\n To estimate the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis (final classification).</li>\n <li>\n To estimate the incidence of cerebral malaria (malaria diagnosed by rapid diagnostic test [RDT] and/or microscopy).</li>\n <li>\n To estimate the mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]), overall and by gender.</li>\n <li>\n To describe risk factors for AESI, other AE leading to hospitalisation or death, meningitis, and malaria.</li>\n <li>\n To describe the causes of hospitalisation (including AESI, other AE, meningitis and malaria).</li>\n <li>\n To describe the causes of death, overall and by gender.</li>\n <li>\n To assess the risk of febrile convulsions during the 7-day period and 1-month period following each dose of RTS,S/AS01E.</li>\n <li>\n To monitor trends over time of meningitis cases identified at site level (first line laboratory).</li>\n <li>\n To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n <li>\n To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed and/or probable meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n <li>\n To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n <li>\n To assess the potential association between vaccination and AESI, and other AE leading to hospitalisation or death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n <li>\n To assess the potential association between vaccination and cerebral malaria by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n <li>\n To assess the potential association, overall and by gender, between vaccination and death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E.</li>\n</ol>\n<div>\n <strong>The specific objectives to assess vaccine effectiveness and impact are;</strong></div>\n<div>\n  </div>\n<div>\n To estimate the vaccine effectiveness (direct effect) and the impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on the incidence of any malaria (including P. falciparum malaria), severe malaria (including P. falciparum malaria) and cerebral malaria diagnosed by RDT and/or microscopy.</div>\n<div>\n  </div>\n<div>\n To estimate the vaccine effectiveness (direct effect) and impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on:</div>\n<ul>\n <li>\n the prevalence of anaemia among hospitalised children.</li>\n <li>\n the incidence of all-cause hospitalisations and hospitalisations attributed to malaria (including P. falciparum).</li>\n <li>\n the mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]) overall and by gender.</li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n Study participants’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.</li>\n <li>\n Written informed consent provided from either the parent(s) or LAR of the study participant.</li>\n <li>\n Study participant living in the HDSS or equivalent surveillance system area.</li>\n <li>\n For enrolment in the active surveillance – DTP group: children must be aged < 18 months, identified at any administration of DTP/HepB/Hib (or at hospitalisation before 3rd dose of DTP/HepB/Hib in case of hospitalisation and vaccinated with at least one dose of DTP/HepB/Hib). (This group will include children from exposed and unexposed clusters.) </li>\n</ol>\n<p style=\"margin-left: 40px;\">\n OR </p>\n<p style=\"margin-left: 40px;\">\n For enrolment in the active surveillance – Catch-up group: children must be aged < 18 months, received at least one dose of DTP/HepB/Hib vaccine, whose age corresponds to the age after the 3rd dose of DTP/HepB/Hib vaccine and identified at administration of first dose of RTS,S/AS01E vaccine. (This group will include children from exposed clusters only.) </p>\n<p style=\"margin-left: 40px;\">\n OR </p>\n<p style=\"margin-left: 40px;\">\n For enrolment in the enhanced hospitalisation surveillance: children must be aged < 5 years and hospitalised at any time during the study. (This group will include children from exposed and unexposed clusters.)</p>\n<ul>\n <li>\n Parents/LARs of children meeting all eligibility criteria for active surveillance, not having completed the visits for DTP/HepB/Hib, and first identified during hospitalisation, must first be proposed enrolment in active surveillance (if recruitment is not completed).</li>\n <li>\n Children already enrolled in active surveillance will have hospitalisation monitored as part of the procedures related to the active surveillance and can therefore not be enrolled in enhanced hospitalisation surveillance.</li>\n</ul>\n
      • principal_exclusion_criteria<ol>\n <li>\n Child in care</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Incidence of AESI, and of other AEs leading to hospitalization or death, in children vaccinated with RTS,S/AS01E.</li>\n <li>\n Incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E.</li>\n</ol>\n<div>\n  </div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n The Epidemiological surveillance will be conducted by KEMRI/CGHR in Bondo and Gem Sub-counties of Siaya County. Recruitment will be done at all vaccinating health facilities in the sub-counties for active surveillance, and study staff will be stationed at the vaccinating facilities. Study Clinicians will be based in 3 main admitting facilities that is Siaya County Referral Hospital, Bondo and Yala Sub-county Hospitals. They will also visit other admitting facilities on regular basis to recruit for active surveillance and enhanced hospital surveillance if there is reported admission of children under 5 years.</div>\n<div>\n  </div>\n<div>\n The key study staff will include the following:</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Co-PI – Dr. Simon Kariuki, PhD</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Co-PI and Study Pediatrician – Dr. Martina Oneko, MD, Paed </div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Study Medical Officer – Dr. Paul Ndaya Oloo, MD, MSc</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Study Coordinator – Benard Ochieng, MSc</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Lab Manager – Kephas Otieno, MSc</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Data Manager – Isaiah Omondi, BSc</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Regulatory Affairs Officer – Elizabeth Wanza , BScN</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Pharmacist – Dr. Tony Sang, BPharm</div>\n<div style=\"margin-left: 40px;\">\n  </div>\n<div>\n Additionally, we will have the following personnel:</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Medical Officer - 1</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Field coordinators - 2</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Clinical Officers - 6</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Laboratory Staff - 4</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Data Officers - 4</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>QA/QC officers - 2</div>\n<div style=\"margin-left: 40px;\">\n •<span style=\"white-space:pre\"> </span>Community interviewers- 30</div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n The evaluation is to be done in Kenya because Kenya is one of the countries selected for the pilot implementation of RTS,S/AS01E Malaria vaccine. </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration62 months
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNo vaccine
      • 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_statesThree countries
      • number_of_sites2 main sites; Bondo and Gem sub-counties in Siaya County
      • multi_country_listKenya\nMalawi\nGhana
      • data_monitoring_committeeNo
      • total_enrolment_per_site6000 children in the active surveillance
      • total_participants_worldwide45,000 children in the active surveillance
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSimon
      • investigator1_middle_name
      • investigator1_family_nameKariuki
      • investigator1_qualificationPhD
      • investigator1_professional_addressKEMRI CGHR, P.O. Box 1578, KIsumu , Kenya
      • investigator1_telephone+254 725 389246
      • investigator1_emailskariuki@kemricdc.org
      • organisations_transferred_No
      • number_participants6000 children in the active surveillance
      • notification
      • approval_date17-05-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-13 11:01:39
      • created2019-03-07 10:49:33
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id479
        • application_id770
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI CGHR, P.O. Box 1578, KIsumu , Kenya
        • telephone+254 725 389246
        • emailskariuki@kemricdc.org
        • created2019-03-07 11:07:29
        • modified2020-03-25 12:01:44
      • 1(array)
        • id480
        • application_id770
        • given_nameMartina
        • middle_name
        • family_nameOneko
        • qualificationMD
        • professional_addressKEMRI CGHR, P.O. Box 1578, KIsumu , Kenya
        • telephone+254 717 747279
        • emailmoneko@kemricdc.org
        • created2019-03-07 11:28:09
        • modified2020-03-25 12:01:44
    • SiteDetail(array)
      • 0(array)
        • id625
        • application_id770
        • county_id41
        • site_nameBondo sub-county
        • physical_addressBondo
        • contact_details+254 723 228468
        • contact_personGeorge Okoth
        • site_capacity(null)
        • misc(null)
        • created2019-03-07 11:07:29
        • modified2020-03-25 12:01:44
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id626
        • application_id770
        • county_id41
        • site_nameGem sub-county
        • physical_addressBondo
        • contact_details+254 721 790484
        • contact_personReuben Yego
        • site_capacity(null)
        • misc(null)
        • created2019-03-07 11:59:39
        • modified2020-03-25 12:01:44
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id374
        • application_id770
        • sponsorGlaxoSmithKline (GSK)
        • sponsor_typeIndustry
        • contact_persongodfrey.n.rikhotso@gsk.com
        • addressGlaxoSmithKline South Africa
        • telephone_number+2711 745 6102
        • fax_number+2711 388 6213
        • cell_number+2779 223 2180
        • email_addressgodfrey.n.rikhotso@gsk.com
        • created2019-03-07 11:07:29
        • modified2020-03-25 12:01:44
  • 3(array)
    • Application(array)
      • id758
      • user_id32
      • trial_status_id6
      • abstract_of_study<div>\n It was recently estimated that in sub-Saharan Africa (SSA) malaria incidence was halved and parasite infection prevalence decreased by 40% from the years 2000–2015. This decrease has largely been attributed to the roll-out of insecticide treated nets (ITNs), and to a lesser degree to indoor residual spraying of insecticide (IRS) and improved case management with rapid diagnostic testing and artemisinin-based combination therapies (ACTs). Despite these gains, in 2016 it was estimated that there were 216 million cases of malaria globally, and 445,000 deaths attributed to malaria, >90% and >80% occurring in children in SSA, respectively. Furthermore, the effectiveness of interventions that have been so successful in reducing the malaria burden in SSA are threatened by insecticide and drug resistance. Therefore, new tools are needed to combat malaria, particularly those targeting vulnerable populations like children.</div>\n<div>\n The RTS,S/AS01 malaria vaccine has been developed to prevent clinical disease caused by the malaria parasite Plasmodium falciparum, the most deadly of the malaria parasites that infect humans. A Phase 3 clinical trial was conducted in 15,459 infants and children in 11 different sites in 7 countries in SSA from 2009 to 2014. Results of this trial confirmed moderate, but significant protection against clinical malaria — in the 12 months following vaccination, clinical malaria was reduced by 51% (95% Confidence Interval [CI] 47–55%), and the incidence of severe malaria was reduced by 44.5% (95% CI 24–60%) in children aged 5–17 months at the time of first vaccination. However, vaccine efficacy (VE) waned over time. In successive 6 month periods after the third dose, VE waned from 68% to 39% to 28%, for an overall VE of 46% against clinical malaria and 38% against severe malaria 18 months after the third dose. A booster dose given 18 months after the third dose, and evaluated over the entire 4-year study increased VE from 26% to 39% against clinical malaria and from -2% to 31.5% against severe malaria. Vaccine efficacy in the cohort of infants vaccinated (6-12 weeks at time of first vaccination) was substantially lower.</div>\n<div>\n While no fatal adverse events were assessed to be causally related to RTS,S/AS01 vaccination, and while the overall incidence of SAEs was lower in children receiving the vaccine than in those who did not, febrile convulsions were found to be a risk in the 7-day period after vaccination. Additionally, more cases of meningitis were identified in the children vaccinated with RTS,S/AS01 than in the comparison group (relative risk [RR] 8.0 (95% CI 1.1–60.3)), and unplanned exploratory analyses revealed increased cases of cerebral malaria (CM) in the RTS,S/AS01 group and more deaths from all causes combined in vaccinated girls compared to the control group. While the increase in febrile seizures is explained by the association between vaccination and increased risk of fever, the potential safety signals of meningitis, CM, and increased deaths in girls have not been demonstrated to be causally related, and were considered likely chance findings.</div>\n<div>\n The European Medicines Agency (EMA) reviewed available data in mid-2015 and provided a positive scientific opinion on the benefit/risk balance of RTS,S/AS01 in children aged 5 to 17 months of age, accepting a proposed risk management plan which included a Phase 4 study to investigate the observed safety signals. The World Health Organization’s (WHO) expert advisors on vaccination and malaria advisory committees reviewed the data and the EMA opinion in late 2015, and recommended phased pilot implementation of the vaccine in moderate to high malaria transmission settings to assess: 1) the programmatic feasibility of achieving high coverage with three to four new contacts, including the fourth dose of vaccine, 2) the vaccine’s impact on all-cause mortality, and 3) the vaccine’s safety in the setting of  a routine immunization program with special interest into the safety signals of meningitis and CM.</div>\n<div>\n The Malaria Vaccine Implementation Programme (MVIP), which is comprised of the phased roll-out of the RTS,S/AS01 vaccine in 120,000 children in each of Ghana, Malawi, and Kenya by the Ministries of Health of each country, Phase 4 studies sponsored by GlaxoSmithKline, and a WHO-led Malaria Vaccine Pilot Evaluation (MVPE), will begin in 2019. A Master Protocol (Annex 2) has been developed by WHO to guide the consortia of partners from the various countries who will be evaluating the vaccine so that data can be compared and analysed between countries. This protocol describes the specific design, methodologies, and procedures that the MVPE consortium will use to evaluate the feasibility, impact, and safety of the vaccine roll-out in Kenya.</div>\n<div>\n  </div>\n
      • study_title<div>\n <p>\n An evaluation of the cluster-randomised pilot implementation of the RTS,S/AS01 malaria vaccine through routine health systems in western Kenya </p>\n</div>\n<p>\n  </p>\n
      • laymans_summary<p>\n Despite significant gains in malaria control in sub-Saharan Africa, malaria continues to be a major cause of disease and death, particularly in children <5 years of age. Control methods currently used by the National Malaria Control Programs have been very successful in reducing the burden, but there is concern that the effectiveness of many of the tools and the first-line antimalarials, including ITNs and ACTs are being threatened by resistance and may no longer be as effective in the near future. A large Phase 3 trial of the RTS,S/AS01 malaria vaccine in >15,000 infants and children was conducted between 2009–2014, and the results of this were promising in that children aged 5–17 months of age who received 4 doses of the vaccine had a 39% reduction in the number of cases and 31.5% reduction in the severe cases of malaria as compared to the children in the study who did not receive the vaccine. However, while these results were promising, there were concerns that there were more cases of febrile seizures, meningitis, and cerebral malaria in children who received the vaccine than in those who did not, and though rare, there were more deaths in girls in the vaccinated groups than in the unvaccinated groups. While the findings of increased febrile seizures are explained by an association of an increased risk of fevers with the vaccine, the scientific opinion was that the increase in meningitis and cerebral malaria were due to chance and the design of the study, and not to the vaccine itself. In 2015, after reviewing the available data on the vaccine, the European Medicines Agency (EMA) gave a positive scientific opinion of the benefit/risk balance of the vaccine in children aged 5-17 months, and accepted a proposed risk management plan to evaluate the safety signals of meningitis and cerebral malaria in larger Phase 4 studies of the vaccine. Following the EMA’s positive scientific opinion, the WHO’s vaccine experts and malaria advisory committees recommended phased roll-outs of the vaccine by the Ministries of Health in 120,000 children aged 5-17 months in 3 countries (later identified as Ghana, Malawi, and Kenya). The primary objectives of these phased roll-outs is to evaluate, 1) the feasibility of achieving high coverage of 4 doses of the vaccine in the target population, understanding that this may mean up to 3-4 new contacts per child, 2) the impact of rolling out the vaccine on all-cause mortality, and 3) the safety of the vaccine in the context of a programmatic roll-out with specific attention to the signals of cerebral malaria and meningitis. In 2019, the Ministries of Health in Ghana, Malawi, and Kenya will roll-out this vaccine, and partners within each country will evaluate the aforementioned three objectives. The WHO has prepared a master protocol (Appendix 1) to guide the evaluation partners in each of the countries so that their data may be compared and analyzed together. This protocol describes the specific design, methods, and procedures for evaluating the phased roll-out by the consortium in Kenya.</p>\n
      • short_titleEvaluation of the RTS,S vaccine implementation in Kenya (MVPE)
      • protocol_noECCT/19/06/03
      • version_no3.1
      • date_of_protocol11-03-2019
      • study_drugMalaria Vaccine (RTS,S, AS01E) - MVPE
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • 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_pi0
      • 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_applicantDr Tony Sang
      • declaration_date121-06-2019
      • declaration_principal_investigatorDr Aaron Samuels
      • declaration_date221-06-2019
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size: 14px;\"><strong>Research questions and objectives</strong></span></p>\n<p>\n <strong>Key questions on impact, safety, and feasibility</strong></p>\n<p>\n The following key questions will be evaluated in groups of children, aged 5-39 months, who have or have not received one or more doses of RTS,S/AS01.</p>\n<p>\n  </p>\n<p>\n <strong>Impact:</strong></p>\n<ul>\n <li>\n Does the routine delivery of RTS,S/AS01 result in a reduction in all-cause mortality of at least 10%?</li>\n <li>\n Does the routine delivery of RTS,S/AS01 result in differences in gender-specific all-cause mortality, age-specific all-cause mortality, or malaria-specific mortality?</li>\n</ul>\n<p>\n <strong>Safety:</strong></p>\n<ul>\n <li>\n Does the routine delivery of RTS,S/AS01 result in a difference in the incidence of a) probable and confirmed meningitis or b) cerebral malaria among children admitted to sentinel hospitals?</li>\n <li>\n  Does the frequency and profile of meningitis and cerebral malaria among admitted to sentinel hospitals, differ by vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus unvaccinated)?</li>\n</ul>\n<p>\n <strong>Feasibility:</strong></p>\n<ul>\n <li>\n What coverage can be achieved with RTS,S/AS01 (including the fourth dose in the second or third year of life)?</li>\n <li>\n What is the coverage of recommended EPI vaccines (including MCV2) and does it change with RTS,S/AS01 introduction?</li>\n <li>\n What is the coverage and utilization of other recommended malaria prevention and control measures, including ITN and IRS, and does it change with RTS,S/AS01 introduction?</li>\n <li>\n Do treatment seeking behaviors for febrile children, use of malaria prevention measures, and EPI vaccination coverage change with the introduction of RTS,S/AS01? If so, why?</li>\n <li>\n Does the introduction of RTS,S/AS01 alter the coverage of other key childhood interventions, including anti-helminth administration (deworming) and Vitamin A supplementation?</li>\n <li>\n What is the acceptability of the RTS,S/AS01 vaccine, and what are the barriers and facilitators of RTS,S/AS01 vaccination?</li>\n</ul>\n<p>\n  </p>\n<p>\n The overall impact of RTS,S/AS01 will be evaluated in the malaria vaccine program evaluation. As with other vaccines, any risks identified need to be weighed against the benefits to understand the overall impact of the vaccine. The overall assessment will consider both feasibility and impact outcomes. The evaluation of risks and benefits will be made by the Data Safety Monitoring Board and presented to WHO’s Global Advisory Committee on Vaccine Safety (GACVS), SAGE, and MPAC to develop the WHO policy recommendation on the large-scale deployment of the RTS,S/AS01 vaccine.</p>\n<p>\n  </p>\n<p>\n <strong>Objectives related to impact and community-based surveillance</strong></p>\n<ul>\n <li>\n <em>Primary impact objective</em>\n <ul>\n <li>\n To estimate the effect of routine vaccine delivery on all-cause mortality in children aged 5–39 months, comparing by vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus non-vaccinated)</li>\n </ul>\n </li>\n <li>\n <em>Secondary impact objectives</em>\n <ul>\n <li>\n To estimate the effect of routine vaccine delivery on gender-specific all-cause mortality, age-specific all-cause mortality, all-cause mortality excluding non-malaria causes of death (such as trauma, poisoning, drowning, and other agreed upon causes), cause-specific mortality, and malaria-specific mortality in children aged 5-39 months</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Objectives related to safety and surveillance in sentinel hospitals</strong></p>\n<ul>\n <li>\n <em>Primary safety objectives</em>\n <ul>\n <li>\n To estimate the incidence of a) probable and confirmed meningitis and b) cerebral malaria in children admitted to sentinel hospitals, and compare by vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus non-vaccinated) among children aged 5-39 months admitted to sentinel hospitals</li>\n </ul>\n </li>\n <li>\n <em>Secondary safety objectives</em>\n <ul>\n <li>\n To estimate the relative risk of meningitis, cerebral malaria, severe malaria, all-cause hospital admissions, malaria-associated hospital admissions, non-malaria hospital admissions (overall and by cause), malaria-associated hospital mortality, cerebral malaria-associated hospital mortality, serious adverse events, and anemia, based on vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus non-vaccinated), among children aged 5–39 months admitted to sentinel hospitals. These will be agreed upon with the NVIP and with the Data Safety and Monitoring Board (Annex 4).</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Objectives related to feasibility</strong></p>\n<ul>\n <li>\n <em>Primary feasibility objectives</em>\n <ul>\n <li>\n To estimate the proportion of children aged 12–23 months who had received three doses of RTS,S/ASO1 by 12 months of age (midline survey), and the proportion of children aged 27-38 months who had received their fourth dose of RTS,S/AS01 by 27 months of age (endline survey)</li>\n </ul>\n </li>\n <li>\n <em>Secondary feasibility objectives</em>\n <ul>\n <li>\n To estimate the coverage of recommended EPI vaccines (as fully vaccinated and for each individual dose), coverage and utilization of recommended malaria prevention and control measures (including ITN/LLIN and IRS), characterize health seeking behaviors for febrile children, including hospital admissions, dropout rates and the proportion of fully vaccinated children, and coverage of other key childhood interventions (including anthelmintic administration and vitamin A supplementation) based on vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus non-vaccinated) among children in the target population; and to quantitatively assess the acceptability of the RTS,S/AS01 vaccine, in addition to barriers and facilitators of the RTS,S/AS01 vaccination.</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Children aged 5–48 months living in the eight county implementation and comparison areas.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n None</p>\n
      • primary_end_points<p>\n The following key questions will be evaluated in groups of children, aged 5-39 months, who have or have not received one or more doses of RTS,S/AS01.</p>\n<p>\n Impact:</p>\n<ul>\n <li>\n Does the routine delivery of RTS,S/AS01 result in a reduction in all-cause mortality of at least 10%?</li>\n <li>\n Does the routine delivery of RTS,S/AS01 result in differences in gender-specific all-cause mortality, age-specific all-cause mortality, or malaria-specific mortality?</li>\n</ul>\n<p>\n Safety:</p>\n<ul>\n <li>\n Does the routine delivery of RTS,S/AS01 result in a difference in the incidence of a) probable and confirmed meningitis or b) cerebral malaria among children admitted to sentinel hospitals?</li>\n <li>\n Does the frequency and profile of meningitis and cerebral malaria among admitted to sentinel hospitals, differ by vaccination group (implementing versus comparison areas) or status (RTS,S/AS01 vaccinated versus unvaccinated)?</li>\n</ul>\n<p>\n Feasibility:</p>\n<ul>\n <li>\n What coverage can be achieved with RTS,S/AS01 (including the fourth dose in the second or third year of life)?</li>\n <li>\n What is the coverage of recommended EPI vaccines (including MCV2) and does it change with RTS,S/AS01 introduction?</li>\n <li>\n What is the coverage and utilization of other recommended malaria prevention and control measures, including ITN and IRS, and does it change with RTS,S/AS01 introduction?</li>\n <li>\n Do treatment seeking behaviors for febrile children, use of malaria prevention measures, and EPI vaccination coverage change with the introduction of RTS,S/AS01? If so, why?</li>\n <li>\n Does the introduction of RTS,S/AS01 alter the coverage of other key childhood interventions, including anti-helminth administration (deworming) and Vitamin A supplementation?</li>\n <li>\n What is the acceptability of the RTS,S/AS01 vaccine, and what are the barriers and facilitators of RTS,S/AS01 vaccination?</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n In order to conduct active community-based surveillance in western Kenya, we will build and maintain a network of Village Reporters (VR) to document and report all deaths among children younger than five years of age in the 23 implementation and 23 comparison areas. There will be approximately 25 VRs per cluster, totaling 1,150. Additionally, there will be one VR Technical Supervisor per cluster, totaling 46. The VR Technical Supervisor will be responsible for receiving death notifications from the VRs, conducting Verbal Autopsies (VA), uploading VA data into the database.</p>\n<p>\n The six sentinel hospitals selected for the evaluation by the Kenya Evaluation Consortium are high volume hospitals that admit approximately 1,500-3,000 children annually within the age range of interest of the evaluation. Approximately 60% of admissions have a positive malaria slide and about 80% of admissions are aged under 5 years. The hospitals have a system for managing patient medical records, including patient history and physical examination signs required for the safety evaluation. The hospitals have a reliable electricity supply, and a functioning laboratory with capacity to perform malaria RDT, blood glucose testing (dip-stick or lab-based), hemoglobin/hematocrit estimation, and cerebrospinal fluid (CSF) macroscopic visual inspection.</p>\n<p>\n The core study team will include qualified, experieced and suitably trained investigators, coordinators quality assurance, laboratory and data staff.</p>\n<p>\n The investigators include:</p>\n<ul>\n <li>\n Dr. Meghna Desai is an epidemiologist and the Chief of the CDC Malaria Branch in Atlanta, GA, USA.</li>\n <li>\n Dr. Aaron Samuels is a medical epidemiologist and the Director of the CDC-Kenya Malaria Research Program.</li>\n <li>\n Dr. Nelli Westercamp is an epidemiologist at the CDC in Atlanta. </li>\n <li>\n Dr. Sarah-Blythe Ballard is a medical epidemiologist at the CDC in Atlanta. </li>\n <li>\n Dr. Simon Kariuki is an immunologist, the Chief of the Malaria Branch at KEMRI-CGHR, and the Chief Research Officer at KEMRI-CGHR. ed in study conduct, analyses and manuscript writing.</li>\n <li>\n Dr. Samuel Akech is a paediatrician at KWTRP based in Nairobi. </li>\n <li>\n Prof Mike English is a paediatrician at KWTRP based in Nairobi and University of Oxford.</li>\n <li>\n Prof Robert Snow is an epidemiologist at KWTRP based in Nairobi and University of Oxford. </li>\n <li>\n Prof Philip Bejon is the director of KWTRP and a clinical epidemiologist. </li>\n</ul>\n<p>\n Medical consultants:</p>\n<ul>\n <li>\n Maj. Nathanial Copeland, M.D., M.T.M.&H.</li>\n <li>\n Dr. Bernhards Ogutu, MBChB, MMed (Paed), PhD</li>\n <li>\n Dr. Walter Otieno, MBChB, MMed (Paed), PhD</li>\n <li>\n Dr. Janet Oyieko, MD, MMed (Paed)</li>\n <li>\n Dr. Valentine Sing’oei, MBChB</li>\n <li>\n Dr. Lucas Otieno Tina, MBChB, MSc</li>\n</ul>\n
      • other_details_explanation<p>\n This evaluation is being fone in kKenya in line with the phased roll-out of the RTS,S/AS01 vaccine</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<ol>\n <li>\n World Health Organisation Research Ethics Review Committee (WHO ERC) approved the protocol on 26 Mar 2019</li>\n <li>\n Oxford Tropical Research Ethics Committee (OxTREC)  approved the protocol on 09 May 2019</li>\n <li>\n Centers for Disease Controll & Precention's Institutional Review Board (CDC's IRB) approved the protocol on 16 May 2019</li>\n</ol>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration49 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNo vaccine
      • 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_countriesNo
      • multiple_member_states
      • number_of_sitesEight counties in the lake-endemic region of Kenya: Bungoma, Busia, Homa Bay, Kakamega, Kisumu, Migori, Siaya, and Vihiga
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAll children aged 5–48 months living in the eight county implementation and comparison areas will contribute data for the mortality surveillance\n\nAll children aged 5–48 months admitted to the selected sentinel hospitals will contribute data for the safety surveillance\n\nIn each sub-county children aged 5-48 months in living in randomly selected 25 households in each of 4 randomly selected enumeration areas will be eligible to participate in the feasibility evaluation baseline and end line surveys. Children aged 12–23 months from a minimum of 600 households will be eligible to participate in the mid line surveys.\n
      • total_participants_worldwideAll children aged 5–48 months living in the eight county implementation and comparison areas will contribute data for the mortality surveillance All children aged 5–48 months admitted to the selected sentinel hospitals will contribute data for the sa
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • 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_nameMeghna
      • investigator1_middle_name
      • investigator1_family_nameDesai
      • investigator1_qualificationMPH, PHD
      • investigator1_professional_addressCDC 1600 Clifton Rd, NE M/S A-06, Atlanta, GA, USA 30329.
      • investigator1_telephone+1 404 718 4752
      • investigator1_emailmud8@cdc.gov
      • organisations_transferred_No
      • number_participantsAll children aged 5–48 months living in the eight county implementation and comparison areas will contribute data for the mortality surveillance\n\nAll children aged 5–48 months admitted to the selected sentinel hospitals will contribute data for the safety surveillance\n\nIn each sub-county children aged 5-48 months in living in randomly selected 25 households in each of 4 randomly selected enumeration areas will be eligible to participate in the feasibility evaluation baseline and end line surveys. Children aged 12–23 months from a minimum of 600 households will be eligible to participate in the mid line surveys.\n\n
      • notification
      • approval_date13-08-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-06 14:50:24
      • created2019-02-04 15:10:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id471
        • application_id758
        • given_nameAaron Samuels
        • middle_name
        • family_nameSamuels
        • qualificationMD, MHS
        • professional_addressCDC-Kenya Malaria Research Program, P.O. Box 1578, Kisumu 40100
        • telephone+254 724 255 633
        • emailamsamuels@cdc.gov
        • created2019-02-04 15:15:22
        • modified2020-07-08 08:38:13
    • SiteDetail(array)
      • 0(array)
        • id597
        • application_id758
        • county_id39
        • site_nameBungoma County
        • physical_addressBungoma County Referral Hospital
        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
        • site_capacity(null)
        • misc(null)
        • created2019-02-04 15:15:22
        • modified2020-07-08 08:38:13
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 1(array)
        • id618
        • application_id758
        • county_id40
        • site_nameBusia County
        • physical_addressBusia County Referral Hospital
        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
        • site_capacity(null)
        • misc(null)
        • created2019-03-07 09:58:54
        • modified2020-07-08 08:38:13
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
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        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
        • site_capacity(null)
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        • created2019-03-07 09:58:54
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          • created2012-06-15 10:27:10
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        • application_id758
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        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
        • site_capacity(null)
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        • created2019-03-07 09:58:54
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          • county_nameKakamega
          • created2012-06-15 10:26:29
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      • 4(array)
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        • application_id758
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        • site_nameKisumu County
        • physical_addressJaramogi Oginga Odinga Teaching and Referral Hospital
        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
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        • site_nameMigori County
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        • contact_detailsMobile: +254.724.255.633; Email: amsamuels@cdc.gov
        • contact_personDr Aaron Samuels
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        • sponsorWorld Health Organization, Geneva, Switzerland
        • sponsor_typeIndustry
        • contact_personDavid Schellenberg
        • addressGeneva, Switzerland
        • telephone_number+41 22 791 5559
        • fax_number
        • cell_number+41 22 791 5559
        • email_addressschellenbergd@who.int
        • created2019-02-04 15:15:22
        • modified2020-07-08 08:38:13
  • 4(array)
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      • id744
      • user_id611
      • trial_status_id6
      • abstract_of_study<p>\n This is an epidemiology study that intends to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa. GlaxoSmithKline (GSK) Biologicals has developed a pre-erythrocytic Plasmodium (P.) falciparum malaria vaccine, RTS,S/AS01E, for routine immunisation of children living in malaria-endemic countries of sub-Saharan Africa (SSA). The World Health Organization (WHO)’s Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) recommended pilot implementations of RTS,S/AS01E in children of 5–17 months of age, in parts of 3-5 distinct epidemiological settings in sub-Saharan Africa , administering 3 doses of the vaccine to children 5-9 months of age in areas of moderate to-high transmission of malaria with a fourth dose administered 15-18 months following the third dose. In April 2017, the WHO Regional Office for Africa announced that the RTS,S/AS01E vaccine will be first introduced in 3 countries (Ghana, Kenya and Malawi) in 2018 through a WHO-coordinated pilot implementation programme, referred to as the Malaria Vaccine Implementation Programme (MVIP). In order to align with the MVIP, the study sites for the GSK Phase IV studies have been, selected from the 3 countries where the RTS,S/AS01E vaccine will be implemented. Sites from Kenya and Ghana (Malawi sites did not participate in EPI-MAL-002) that were part of study EPI-MAL-002 and also Malawi sites will become study sites in EPI-MAL-003 (EPI-MALARIA-003 VS AME (115056)) which will be exposed clusters. EPI-MAL-003 is a post-implementation study that will further evaluate the safety, effectiveness and impact of the vaccine during initial implementation.</p>\n
      • study_title<p>\n A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa.</p>\n
      • laymans_summary<p>\n GlaxoSmithKline (GSK) Biologicals has developed a malaria vaccine, RTS,S/AS01E, for routine immunisation of children living in malaria-endemic countries of sub-Saharan Africa (SSA). RTS,S/AS01E is the first vaccine to be implemented for the prevention of malaria in the paediatric population. The World Health Organization (WHO)’s Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) recommended pilot implementations of RTS,S/AS01E in children of 5–17 months of age, in parts of 3-5 SSA countries, administering 3 doses of the vaccine to children 5-9 months of age in areas of moderate to- high transmission of malaria with a fourth dose administered 15-18 months following the third dose. In April 2017, the WHO Regional Office for Africa announced that the RTS,S/AS01E vaccine will be first introduced in 3 countries (Ghana, Kenya and Malawi) through a WHO-coordinated pilot implementation programme, referred to as the Malaria Vaccine Implementation Programme (MVIP). In order to align with the MVIP, the study sites for the GSK Phase IV studies have been, selected from the 3 countries where the RTS,S/AS01E vaccine will be implemented. Sites from Ghana and Kenya that were part of study EPI-MAL-002 should become study sites in EPIMAL- 003 which will be exposed clusters. The safety and efficacy of RTS,S/AS01E have been evaluated during pre-authorisation clinical trials conducted mainly in SSA. Study EPI-MALARIA-003 VS AME (115056) will further evaluate the safety, effectiveness and impact of the vaccine during initial implementation. A pre-implementation (i.e. before vaccine implementation) surveillance study, EPI-MALARIA-002 VS AME (115055) will measure the baseline incidence of protocol-defined adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis, malaria morbidity and mortality. The mortality rate, overall and by gender, are also being estimated. EPI-MAL-003 is intended primarily as a post-implementation safety study, together with vaccine effectiveness and impact estimations. In parallel with both EPI-MAL-002 and EPI-MAL-003, a third study (EPI-MALARIA-005 BOD AME [116682] is conducted to measure malaria transmission intensity and other malaria control interventions as confounding factors in the study site areas. The three studies will be conducted in similar if not identical settings. A strong capacity development component is included in the baseline study EPIMAL-002. The study staff (e.g. health care/field worker) will visit the study participant at home or at the local health care facility up to 11 times during the study. Each of these planned study visits should take about 1 hour. If the child takes part in the study and if he/she is found to be unwell at any of the study visits (visits 1 to 9), he/she will be referred to a health care facility and treated under existing Kenya Ministry of Health services/programs. If the medical problem cannot be treated at home or at the nearest health care facility, he/she will be referred to a hospital. If this were to happen, transport will be arranged for this visit to see the doctor. The participant will benefit from regular check-up and advice during the planned visits.</p>\n
      • short_titleEPI 003
      • protocol_noECCT/18/11/02
      • version_no1
      • date_of_protocol11-10-2017
      • study_drugMOSQUIRIX
      • disease_conditionMALARIA
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
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      • email_addressdotigondi3@gmail.com
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      • declaration_applicantDr Bernhards Ogutu
      • declaration_date119-11-2018
      • declaration_principal_investigatorDr Berhnards Ogutu
      • declaration_date219-11-2018
      • placebo_presentNo
      • study_objectives<p>\n Primary objectives • To estimate the incidence of protocol-defined potential adverse events of special interest (AESI), and of other adverse events (AE) leading to hospitalisation or death, in children vaccinated with of RTS,S/AS01E. • To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E. Secondary objectives Safety In children enrolled in EPI-MAL-003 study (vaccinated with RTS,S/AS01E or not vaccinated with RTS,S/AS01E): • To estimate the incidence of aetiology-confirmed and/or probable meningitis (final classification). • To estimate the incidence of probable meningitis (final classification). • To estimate the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis (final classification). • To estimate the incidence of cerebral malaria (malaria diagnosed by rapid diagnostic test [RDT] and/or microscopy). • To estimate the mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]), overall and by gender. • To describe risk factors for AESI, other AE leading to hospitalisation or death, meningitis, and malaria. • To describe the causes of hospitalisation (including AESI, other AE, meningitis and malaria). • To describe the causes of death, overall and by gender. • To assess the risk of febrile convulsions during the 7-day period and 1-month period following each dose of RTS,S/AS01E. In children enrolled in EPI-MAL-002 or EPI-MAL-003 studies (vaccinated with RTS,S/AS01E or not vaccinated with RTS,S/AS01E): • To monitor trends over time of meningitis cases identified at site level (first line laboratory). • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed and/or probable meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and AESI, and other AE leading to hospitalisation or death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and cerebral malaria by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association, overall and by gender, between vaccination and death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. Effectiveness and impact • To estimate the vaccine effectiveness (direct effect) and the impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on the incidence of any malaria (including P. falciparum malaria), severe malaria (including P. falciparum malaria) and cerebral malaria diagnosed by RDT and/or microscopy. • To estimate the vaccine effectiveness (direct effect) and impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on: o The prevalence of anaemia among hospitalised children. o The incidence of all-cause hospitalizations and hospitalizations attributed to malaria (including P. falciparum). o The mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]) overall and by gender.</p>\n
      • principal_inclusion_criteria<p>\n Study participants’ parent(s)/LAR(s) who, in the opinion of the investigator can comply with the requirements of the protocol • Written Informed Consent provided from either the parent(s) or LAR of the study participant • Study participant living in the HDSS or equivalent surveillance system area For enrolment in the active surveillance – DTP group: children must be aged < 18 months, identified at any administration of DTP/HepB/Hib (or at hospitalisation before 3rd dose of DTP/HepB/Hib in case of hospitalisation and vaccinated with at least one dose of DTP/HepB/Hib). (This group will include children from exposed and unexposed clusters.) OR For enrolment in the active surveillance – Catch-up group: children must be aged < 18 months, received at least one dose of DTP/HepB/Hib vaccine, whose age corresponds to the age after the 3rd dose of DTP/HepB/Hib vaccine and identified at administration of first dose of RTS,S/AS01E vaccine. (This group will include children from exposed clusters only.) OR For enrolment in the enhanced hospitalisation surveillance: children must be aged < 5 years and hospitalised at any time during the study. (This group will include children from exposed and unexposed clusters.)</p>\n
      • principal_exclusion_criteria<p>\n Child in care</p>\n
      • primary_end_points<p>\n • Occurrence of AESI. • Occurrence of other AE leading to hospitalisation or death • Occurrence of aetiology-confirmed meningitis</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Principal Investigator- 1 Dr Bernhards Ogutu Sub Investigators-------3 Dr Allan Otieno Dr Fredrick Olewe Dr John Michael Ongecha Clinical Officers--------2 James Otieno Oloo Solomon Ali Juma Study Coordinator-----1 Nelly Koskei Lab Technologists-----2 Grace Owino Kennedy Ogweno Nurses------------------4 Mrs Agnes Onyango Maureen Mbija Wyclife Misiayi Jael Aran Lab Technician--------1 Festus Okute Pharmacist ------------1 Dr Ruth Wasuna Pharmacy Technician-1 Mathew Onyango Data Clerks-------------2 Erick Otiu Dishon Yoweri Odidi Community Health Worker-1 Florence Adhola Community Health Volunteers—10 Site Facilities------ 24 Facilities ( Level 3 and level 4 facilities) out of which 3 can hospitalize. Ahero Sub County Hospital is the referral point for all the facilities Nyando Sub County. The patients are referred to Jaramogi Oginga Odinga Teaching and Referral Hospital from Ahero County Hospital in case of an emergency.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Ghana FDA only acknowledged on 14Sep2018, approval was not sought. Malawi submission to Regulatory Authorities is not applicable</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration62MONTHS
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites3
      • multi_country_listGhana, Malawi, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site• Ahero Clinical Trials Unit (Dr Bernhards Ogutu) – 3000 patients\n• KEMRI Walter Reed Army Institute of Research (Dr Walter Otieno) – 3000 patients\n• KEMRI CDC Siaya (Dr Simon Kariuki) – 6000 patients\n
      • total_participants_worldwide45,000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyCHILDREN LESS THAN 5 YEARS OLD
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBERNHARDS
      • investigator1_middle_name
      • investigator1_family_nameOGUTU
      • investigator1_qualificationMBChB, MMed (Peds), PhD
      • investigator1_professional_addressP.O.BOX 54, AHERO CLINICAL TRIALS CENTRE
      • investigator1_telephone+254 733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants12,000
      • notification<p>\n This submission has been done on behalf of the 3 Kenyan sites. The other 2 sites will only now submit their site specific documents for approval once the ethics approval has been obtained.</p>\n
      • approval_date25-03-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
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      • balance_site(null)
      • final_date(null)
      • modified2025-02-10 11:41:44
      • created2018-11-19 17:44:19
      • total_sites(null)
      • ecitizen_invoice(null)
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        • professional_addressP.O.BOX 54, AHERO CLINICAL TRIALS CENTRE
        • telephone+254 733812613
        • emailogutu6@gmail.com
        • created2018-11-19 17:46:29
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        • contact_personDr Bernhards Ogutu
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        • created2018-11-19 19:39:14
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        • id361
        • application_id744
        • sponsorGlaxoSmithKline Biologicals
        • sponsor_typeIndustry
        • contact_personGodfrey Rikhotso
        • addressFlushing Meadows Building, 57 Sloane Street, The Campus, Bryanston, 2021, Gauteng, South Africa
        • telephone_number+27 11 745 6102
        • fax_number+27 11 388 6213
        • cell_number+27 79 223 2180
        • email_addressgodfrey.n.rikhotso@gsk.com
        • created2018-11-19 17:46:29
        • modified2020-03-04 14:45:38
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    • 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