A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
Phase 2
Completed
- Conditions
- InfluenzaSwine-origin A/H1N1 Influenza
- Registration Number
- NCT01089660
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.
The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.
- Detailed Description
All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine. 21 days post-vaccination
- Secondary Outcome Measures
Name Time Method