NCT00258830

Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)

• 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 during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone®: Influenza Virus Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone®: Influenza Virus Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-02-01
• Completion: 2007-03-01
• First posted: 2005-11-28
• Last updated: 2016-04-14
• Results posted: 2009-06-03

Locations

1 site across 1 country: United States