NCT00835926

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

Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed description

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Influenza virus vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2009-02-04
• Last updated: 2016-04-14
• Results posted: 2009-10-26

Locations

1 site across 1 country: United States