CTRI/2010/091/000204
Completed
Phase 3
Comparative Study to Evaluate the Safety and Immunogenicity of Bharat Biotech Bivalent Oral Poliomyelitis Vaccine Type1 & 3, Live (Oral) Vs Reference Vaccine. (Non- inferiority trial)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited
- Enrollment
- 288
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written and signed informed consent by subject parents or legally acceptable guardian.
- •2\.Healthy male or female full term neonate aged less than three hours at time of enrollment.
- •3\.The delivery was not high\-risk
- •4\.The APGAR score was greater than 7 when measure 1 minute after birth
- •5\.Subjects should have been born after 36\-week term and are not less than 2500 gms, at the time of inclusion.
- •6\.Family does not plan to move during the study period, and housed not further that 50 km away from the study site.
Exclusion Criteria
- •1\)Fever of any origin or infections.
- •2\)Any confirmed or suspected immunosuppressive condition.
- •3\)Any treatment with immunosuppressive or immuno stimulant therapy
- •4\)Use of any marketed or investigational medicine or non\-registered drug or vaccine for polio.
- •5\)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Outcomes
Primary Outcomes
Not specified
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