CTRI/2010/091/000082CompletedPhase 1
A Phase I clinical trial to assess safety of the Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemic) in Adults
Serum Institute of India Limited SII0 sites50 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1) Normal healthy subjects of 18-49 years age at the time of screening. 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. Acute febrile illness or acute infectious disease 5.History of a previous severe allergic reaction. 6. History of H1N1 Influenza infection or any influenza vaccination. 7. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen. 8.History of Guillain-Barré Syndrome. 9. Known history of a bleeding disorder
Investigators
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