A clinical trial of influenza(H1N1) vaccine (Live attenuated) in Adults.
- Registration Number
- CTRI/2010/091/000008
- Lead Sponsor
- Serum Institute of India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1) Normal healthy subjects of 18-49 years age at the time of screening.
2)Free of obvious health problems
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 or had acute respiratory illness in the previous 7 days. 6. Subject with nasal pathology, History of allergic rhinitis, asthma or administration of any intranasal medication. 7. History of a previous severe allergic reaction. 8. History of H1N1 Influenza infection or any influenza vaccination. 9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.10. History of Guillain-Barré Syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety- Solicited, unsolicited, serious adverse events and New onsent Chronic Medical conditionTimepoint: Solicited adverse reaction for day 7 and unsolicited, serious adverse events and New onsent Chronic Medical conditions through out subject participation period. period.
- Secondary Outcome Measures
Name Time Method Mucosal immunity and viral replicationTimepoint: Till day 7