Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 26989548 Date registered: 2015-10-02 Trial Status: Completed TRIAL DESCRIPTION Public title Safety and immunogenicity study of GSK Biologicals’ Official scientific title A Phase 2, randomised, observer-blind, controlled, Brief summary describing the background and objectives of the trial The present Phase 2, randomised, controlled trial will aim at collecting safety and immunogenicity data following a single intramuscular (IM) dose of the investigational ChAd3-EBO-Z vaccine. The study will be conducted in healthy children living in countries adjacent to the current Ebola outbreak zones. Type of trial Prevention Acronym (If the trial has an acronym then please provide) GSK Ebola Paed Disease(s) or condition(s) being studied Ebola Purpose of the trial Anticipated trial start date 2015-10-21 Actual trial start date 2015-10-21 Anticipated date of last follow up 2017-05-10 Actual date of last follow up 2017-05-10 Anticipated target sample size (number of participants) 608    Actual target sample size (number of participants) 608    Recruitment status Not yet recruiting No Secondary ID Issuing authority/Trial register 1 NAFDAC/DER/CT/GSK/HALT-IT/2004/VOL.1 NAFDAC 2 NHREC/01/01/2007 NHREC STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group ChAd3-EBO-Z 1ml day 0 and 1ml month 6 intramascular injection 300 Active Experimental group Nimenrix 1ml day 0 and 1ml month 6 intramascular injection 300 Active ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee 0000-00-00 2015-07-21 JUTH Ethics Committee Ethics Committee Address Street address City Postal code Country Josh University Teaching Hospital Jos 930001 Nigeria 0000-00-00 2015-06-20 NHREC Ethics Committee Address Street address City Postal code Country Federal Ministry of Health, Abuja 0 Nigeria OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Secondary Outcome Anti-GP EBOV antibody titres, as measured by At Day 0 and Day 30, in all subjects, in both groups.  At Month 6 and Month 6 + 30 days, in all subjects in the Group MENACWY-TT/ EBO-Z. Primary Outcome Occurrence of each solicited local and general adverse during a 7-day follow-up period after each vaccination (i.e., the day of vaccination and 6 subsequent days), in all subjects, in both groups. Occurrence of any unsolicited AE, during a 30-day foll RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country Jos University Teaching Murtala Muhammed Road, Old Jos 930001 Nigeria FUNDING SOURCES Name of source Street address City Postal code Country GlaxoSmithKline (GSK) Rue de l’institut 89, Rixensart 1330 Belgium SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor Primary Sponsor GlaxoSmithKline Rue de l’institut 89, Rixensart 1330 Belgium Company COLLABORATORS Name Street address City Postal code Country Quintiles Montrose Place, 2 Bella Rosa Street Bellville 7530 South Africa CONTACT PEOPLE Role Name Email Phone Fax