Immunogenicity Study of the Influenza Vaccine in Adults
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|ClinicalTrials.gov Identifier: NCT00258934|
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : January 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Orthomyxoviridae Infections Influenza||Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion, influenza virus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||978 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||September 2008|
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®
- To provide information concerning the immunogenicity of influenza vaccination. [ Time Frame: 21 Days and 2 Years post-vaccination 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258934
|Study Director:||Medical Director||Sanofi Pasteur Inc.|