Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the
licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),
and the investigational TIV containing the alternate B (B2) strain in children.
Primary Objective:
To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011
TIV (containing the primary B strain) and investigational TIV (containing the alternate B
strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains
separately among children aged 6 months to less than 9 years of age
Secondary Objective:
To demonstrate superiority of antibody responses to each B strain in QIV compared with
antibody titers following vaccination with the TIV that does not contain the corresponding B
strain, as assessed by GMT ratios and seroconversion rates.
Observational Objective:
To describe the safety profile of QIV among subjects 6 months to less than 9 years of age,
as assessed by solicited injection site and systemic adverse events (AEs) collected for 7
days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination,
and adverse events of special interest and serious adverse events (SAEs) collected from
Visit 1 to Visit 2.
Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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