NCT00988143

A Study of Influenza Virus Vaccines in Children and Adults

Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives: * To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age. * To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	2009-2010 Trivalent Influenza Virus Vaccine	0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.
BIOLOGICAL	2008-2009 Trivalent Influenza Virus Vaccine	0.25 mL, Intramuscular; 0.5 mL, Intramuscular.
BIOLOGICAL	Quadrivalent Influenza Virus Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2009-10-02
• Last updated: 2013-12-12
• Results posted: 2013-12-12

Locations

4 sites across 1 country: United States