Influenza Clinical Trial
Official title:
Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine
(QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune
response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).
Primary Objective:
- To describe the safety profile (injection site reactions and systemic events) of each
vaccine during the 21 days following vaccination, and serious adverse events (including
adverse events of special interest) throughout the study in all adult and
child/adolescent participants.
Secondary Objectives:
- To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine
(QIV) induce an equivalent immune response at 21 days post-vaccination in both age
groups (lot consistency)
- To describe the compliance of the immunogenicity of QIV to the European Medicines
Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
All participants will receive a single injection of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2), and also monitored for safety for up to 6 months post-vaccination. ;
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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