A multicentric clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults, Elderly and Children.
Phase 2
Completed
- Registration Number
- CTRI/2010/091/000093
- Lead Sponsor
- Serum Institute of India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
1.Normal healthy subjects of appropriate age. 2.Free of obvious health problems.
Exclusion Criteria
1.Have a known allergy to eggs or other components of the vaccine.2. pregnancy 3. participating in other clinical trial during the present trial period 4. Altered immune status 5. Acute febrile illness or acute infectious disease. 6. History of a previous severe allergic reaction. 7. History of H1N1 Influenza infection or any influenza vaccination. 8. History of Guillain-Barré Syndrome. 9. Known history of a bleeding disorder contraindicating intramuscular vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method