Study to Compare Safety and Immunogenicity of Yellow Fever Vaccine of Serum Institute of India with with STAMARIL

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2022
INTERVENTION: SII YF vaccine Stamaril CONDITION: ; Yellow Fever Yellow Fever PRIMARY OUTCOME: Geometric mean titre GMT Percentage of participants showing seroprotection Percentage seroconversion on Day 28 post‐vaccination; Seroconversion is defined as a four‐fold rise in YF NAb (PRNT50) titres from baseline SECONDARY OUTCOME: All unsolicited adverse events in all participants Immediate adverse events in all participants Post‐vaccination reactogenicity (in reactogenicity cohort) ; 1. Solicited local adverse events ; 2. Solicited systemic adverse events Serious adverse events in all participants INCLUSION CRITERIA: 1. Male or female volunteers aged = 1 to < 60 years 2. Healthy volunteers as determined by medical history and clinical examination 3. Participants willing to adhere to the protocol requirements and to provide informed consent for participants = 18 years of age. For participants < 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants at least 7 years of age in Kenya) 4. Intend to remain residing in study area throughout study participation 5. Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post‐vaccination. *Females can be considered not of childbearing potential only if they are pre‐menarche and less than 12 years of age, or w
Epistemonikos ID: b4798d89ba4d838632812cf009472928aec41fd5
First added on: Aug 25, 2024