NCT01691339

Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective: * To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Detailed description

Participants 18 to \< 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation	0.5 mL, Intramuscular
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation	0.1 mL, Intradermal
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation	0.5 mL, Intramuscular
BIOLOGICAL	Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation	0.5 mL, Intramuscular

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2013-02-01
• First posted: 2012-09-24
• Last updated: 2013-11-04
• Results posted: 2013-11-04

Locations

4 sites across 1 country: United States