CTRI/2010/091/000591
Completed
Phase 3
COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIA
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Panacea Biotec Limited
- Enrollment
- 272
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants between 6 weeks to 10 weeks of age born healthy (2\.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance ( \<30 km), and not planning to travel away during the entire study period (birth\-1 months)
Exclusion Criteria
- •Newborns requiring hospitalization, birth weight below 2\.50 kg, residence \>30 km from study site, or families expecting to be absent during the 30\-day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study.
Outcomes
Primary Outcomes
Not specified
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