NCT01481454

Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults

Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,701 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza Vaccine (split virion, inactivated)	0.5 mL, Intramuscular
BIOLOGICAL	Quadrivalent Influenza Vaccine (split virion, inactivated)	0.5 mL, Intramuscular
BIOLOGICAL	Quadrivalent Influenza Vaccine (split virion, inactivated)	0.5 mL, Intramuscular
BIOLOGICAL	2011 to 2012 Trivalent Influenza Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-11-29
• Last updated: 2013-03-29

Locations

6 sites across 2 countries: Australia, Philippines