NCT01430819

Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Detailed description

Historically, the annual safety and immunogenicity study of Fluzone vaccine has been conducted in the US in support of licenses held by sanofi pasteur in various countries. Participants will be randomized to receive a dose of either Fluzone® or Fluzone® High-Dose vaccine and will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 1 month.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation	0.5 mL, Intramuscular
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation	0.5 mL, Intramuscular

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-09-08
• Last updated: 2013-05-27
• Results posted: 2013-05-16

Locations

6 sites across 1 country: United States