Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
- Conditions
- InfluenzaPandemic InfluenzaInfluenza A Virus, H1N1 Subtype
- Registration Number
- NCT01053143
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
Primary Objective:
* 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
Secondary Objectives:
* 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.
- Detailed Description
Each study participant will receive one dose of the study vaccine on Day 0, provide pre- and post-vaccination blood samples at 21 and 180 days for immunogenicity testing and undergo safety follow-up for 6 months post-vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 7 days post-vaccination and entire study duration
- Secondary Outcome Measures
Name Time Method To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine. 6 months post-vaccination To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine. 21 days post-vaccination