NCT00524940

Trial to Describe the Safety and Immunogenicity of Fluzone®

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the 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	Inactivated, Split-Virion Influenza Virus	0.5 mL, Intramuscular

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2007-09-05
• Last updated: 2016-04-14
• Results posted: 2009-03-30

Locations

1 site across 1 country: United States