ISRCTN76316509
Completed
N/A
Comparative evaluation of immunogenicity of monovalent type 1 oral poliovirus vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in Egypt
World Health Organization (WHO) (Switzerland)0 sites600 target enrollmentFebruary 1, 2006
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Polio
- Sponsor
- World Health Organization (WHO) (Switzerland)
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Infants born healthy (greater than or equal to 2\.75 kg, apgar score greater than or equal to 9 at five minutes) at the study site(s) (large maternity hospitals)
- •2\. Residing within a relatively short and easily accessible distance (less than 30 km) in the same governorate as the study site
- •3\. Not planning to travel away during entire the study period (birth to two months)
Exclusion Criteria
- •1\. High\-risk newborns will be excluded
- •2\. Newborns requiring hospitalisation
- •3\. Birth weight below 2\.75 kg
- •4\. Apgar score less than 9 at five minutes
- •5\. Residence greater than 30 km from study site (or residing in another governorate)
- •6\. Family is planning to be absent during the 60\-day study period
- •7\. 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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