Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Phase 4
Completed
- Conditions
- Influenza
- Interventions
- Biological: Influenza Virus Vaccine, Fluzone®
- Registration Number
- NCT00390884
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluzone®-Primed Group Influenza Virus Vaccine, Fluzone® Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. Fluzone®-Naive Group Influenza Virus Vaccine, Fluzone® Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
- Primary Outcome Measures
Name Time Method Percentage of Seroprotected Participants Post-vaccination With Fluzone® Day 28 Post-vaccination Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® Day 28 Post-vaccination Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.