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: 0 Date registered: 2023-04-11 Trial Status: Pending TRIAL DESCRIPTION Public title A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children Official scientific title A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children Brief summary describing the background and objectives of the trial Lassa fever (LF) is a severe viral disease endemic to West African countries estimated to cause up to 500 000 LF cases and 10 000 deaths annually. The main objective is to evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children Type of trial Prevention Acronym (If the trial has an acronym then please provide) A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children Disease(s) or condition(s) being studied Lassa Purpose of the trial Anticipated trial start date 2023-06-15 Actual trial start date 2023-07-05 Anticipated date of last follow up 2023-06-26 Actual date of last follow up 2025-10-31 Anticipated target sample size (number of participants) 310    Actual target sample size (number of participants) 310    Recruitment status Not yet recruiting No Secondary ID Issuing authority/Trial register 1 1 1 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 dgrviwoa 1 1 1 Active Control group nbmxyaxi 1 1 1 Active Experimental group opicgrhh 1 1 1 Placebo Control group oeqonksh 1 1 1 Placebo Experimental group bkvtlsmy 1 1 1 Historical Control group lrjwbdsa 1 1 1 Uncontrolled Experimental group djkfgswy 1 1 1 Uncontrolled Control group fwedfgae 1 1 1 Historical Experimental group ncbfnmyn 1 1 1 Dose comparison Control group uoqkquom 1 1 1 Dose comparison 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 0000-00-00 mciacekw Ethics Committee Address Street address City Postal code Country 3137 Laguna Street San Francisco 94102 Afghanistan 0000-00-00 0000-00-00 oohbxeng Ethics Committee Address Street address City Postal code Country 3137 Laguna Street San Francisco 94102 Afghanistan OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Secondary Outcome 1 1 RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country 1 3137 Laguna Street San Francisco 94102 Afghanistan 1 3137 Laguna Street San Francisco 94102 Albania 1 3137 Laguna Street San Francisco 94102 Algeria FUNDING SOURCES Name of source Street address City Postal code Country SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor COLLABORATORS Name Street address City Postal code Country Dr Olufemi Omoz-oarhe Garki Hospital Abuja Abuja 900103 Nigeria Dr Fidelis Bakut Garki Hospital Abuja Abuja 900103 Nigeria Professor Joseph Otubu Garki Hospital Abuja Abuja 900103 Nigeria CONTACT PEOPLE Role Name Email Phone Fax