ISRCTN64725429
Completed
Not Applicable
Comparative evaluation of immunogenicity and reactogenicity of monovalent type 2 and 3 oral poliovirus vaccines (mOPV 2 and mOPV3) versus trivalent oral poliovirus vaccine (tOPV), and bivalent oral poliovirus vaccine (bOPV) versus monovalent types 1 and 3 oral poliovirus vaccines, respectively: a randomised double-blind trial
Panacea Biotec Limited (India)0 sites900 target enrollmentNovember 26, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Panacea Biotec Limited (India)
- Enrollment
- 900
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy newborns (either sex) (greater than or equal to 2\.50 kg birth weight, apgar score at 5 min greater than or equal to 9\) at the study sites (large maternity hospitals)
- •2\. Residing within a relatively short and easily accessible distance (less than 30 km)
- •3\. Not planning to travel away during entire the study period (birth \- 2 months)
Exclusion Criteria
- •1\. Newborns requiring hospitalisation
- •2\. Birth weight below 2\.50 kg
- •3\. Apgar score at 5 min less than 9
- •4\. Residence greater than 30 km from study site
- •5\. Families expecting to be absent during the 60\-day study period
- •6\. 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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