Immunogenicity Study of the Influenza Vaccine in Adults
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.
Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.
Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.
|Orthomyxoviridae Infections Influenza||Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion, influenza virus||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
- To provide information concerning the immunogenicity of influenza vaccination. [ Time Frame: 21 Days and 2 Years post-vaccination 1 ]
|Study Start Date:||September 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Biological: Inactivated, split-virion influenza vaccine
0.1 mL single annual dose
|Active Comparator: 2||
Biological: Inactivated, split-virion, influenza virus
0.5 mL single annual dose
Other Name: Vaxigrip®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258934
|Study Director:||Medical Director||Sanofi Pasteur Inc.|