A Phase I clinical trial to assess safety and immune response of Influenza vaccine of Serum Institute of India Limited in Adults.
Phase 1
Completed
- Registration Number
- CTRI/2011/09/002033
- Lead Sponsor
- Serum Institute of India Ltd Pune India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Normal healthy subjects of 18-49 years age
Exclusion Criteria
1. Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs. 3. Pregnancy and breastfeeding women 4. Subject participating in other clinical trial 5. Altered immune status. 6. Acute febrile illness or acute infectious disease. 7. Any nasal pathology. 8. Asthma. 9. History of allergic reaction. 10. History of serious chronic illness. 11. Guillain-Barré Syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method