NCT01218646

Study of Quadrivalent Influenza Vaccine Among Adults

Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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)

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative	0.5 mL, Intramuscular
BIOLOGICAL	Investigational Trivalent Inactivated Influenza Vaccine, No Preservative	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative	0.5 mL, Intramuscular

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2010-10-11
• Last updated: 2013-10-23
• Results posted: 2013-09-12

Locations

12 sites across 1 country: United States