Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
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|ClinicalTrials.gov Identifier: NCT00545701|
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : January 14, 2014
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.
- To describe the immune response 21 days after each vaccination.
- To describe the safety profiles following each vaccination.
|Condition or disease||Intervention/treatment||Phase|
|Influenza Orthomyxoviridae Infections||Biological: A/H5N1 inactivated, split-virion influenza virus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||September 2008|
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5 mL, Intramuscular
- To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine [ Time Frame: Day 42 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): NCT00545701
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|