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Clinical Trials/CTRI/2010/091/000082
CTRI/2010/091/000082
Completed
Phase 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 enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Serum Institute of India Limited SII
Enrollment
50
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Serum Institute of India Limited SII

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

Outcomes

Primary Outcomes

Not specified

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