Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
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|ClinicalTrials.gov Identifier: NCT01053143|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : January 14, 2014
The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India.
- To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects
- To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects
- To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.
|Condition or disease||Intervention/treatment||Phase|
|Influenza Pandemic Influenza Influenza A Virus, H1N1 Subtype||Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bridging Study on Safety and Immunogenicity of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Study Group
Participants aged 18 years and older at enrollment.
Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)
0.5 mL, Intramuscular
- To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine. [ Time Frame: 7 days post-vaccination and entire study duration ]
- To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine. [ Time Frame: 21 days post-vaccination ]
- To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine. [ Time Frame: 6 months post-vaccination ]
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): NCT01053143
|Chandigarh, India, 160012|
|New Delhi, India, 110001|
|Pune, India, 411043|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|