A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
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.
|Influenza||Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)|
- Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. [ Time Frame: Days 0-3 post-vaccination ]Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
- Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation [ Time Frame: Day 0 and 21 days post-vaccination ]
- Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) [ Time Frame: 21 days post-vaccination ]Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
- Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) [ Time Frame: 21 days post-vaccination ]Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation
|Study Start Date:||August 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Study Group
Participants received one dose of Fluzone® vaccine on Day 0.
Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
0.5 mL, intramuscular
Other Name: Fluzone®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743275
|United States, Virginia|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|