Trial to Describe the Safety and Immunogenicity of Fluzone®
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.
|Influenza||Biological: Inactivated, Split-Virion Influenza Virus||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)|
- Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. [ Time Frame: 0-3 days post-vaccination and entire study duration ]Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. [ Time Frame: 21 days post-vaccination ]GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
|Study Start Date:||August 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Experimental: Study Group||
Biological: Inactivated, Split-Virion Influenza Virus
0.5 mL, Intramuscular
Other Name: Fluzone®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524940
|United States, Virginia|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Medical Director||Sanofi Pasteur Inc|