CTRI/2011/09/002033
Completed
Phase 1
A Phase I clinical trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in Adults.
Serum Institute of India Ltd Pune India0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Serum Institute of India Ltd Pune India
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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