Influenza Clinical Trial
Official title:
Safety and Immunogenicity Trial Among Adults 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, and
the investigational TIV containing the alternate B strain in adult subjects.
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 subjects 65 years of age and older
Observational Objective:
- To describe the safety profiles of TIV among subjects 18 years of age and older and QIV
in subjects 65 years and older, 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.
All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2) ;
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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