ACTRN12612000276853
Recruiting
Phase 4
Comparison of Immunogenicity Of Type 1 Monovalent Oral Polio Vaccine (mOPVl) Administered at Short Intervals with Type 1 Monovalent (mOPVl) And Type 1&3 Bivalent (bOPV1&3) Oral Polio Vaccine Given At Standard Intervals in Healthy Newborns in Pakistan: A Randomized Trial; Aga Khan University, Karachi
WHO0 sites800 target enrollmentMarch 8, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- poliomyelitis
- Sponsor
- WHO
- Enrollment
- 800
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants born healthy (\> 2\.5 kg birth weight, immediate cry, no neonatal IMCI danger signs) at the study sites (home or health facility births assisted by study\-Trained Birth Attendants/other health personnel) and not planning to travel away during entire the study period (birth\-102 days).
Exclusion Criteria
- •High\-risk newborns will be excluded, as well as newborns requiring hospitalization, birth weight below 2\.5 kg, cry \>2 minutes, and with any neonatal IMNCI danger signs, residence \>30 km from study site, or family is planning to be absent during the birth \- 102 day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family \- e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
Outcomes
Primary Outcomes
Not specified
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