NCT00743275

A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation. To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)	0.5 mL, intramuscular

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-08-28
• Last updated: 2016-05-16
• Results posted: 2010-02-23

Locations

1 site across 1 country: United States