ISRCTN18107202
Completed
Not Applicable
Comparative evaluation of Immunogenicity of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) and monovalent type 3 Oral Poliovirus Vaccine (mOPV3) versus trivalent Oral Poliovirus Vaccine (tOPV): a randomised double-blind controlled trial in South Africa
World Health Organization (WHO) (Switzerland)0 sites800 target enrollmentNovember 15, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Poliomyelitis
- Sponsor
- World Health Organization (WHO) (Switzerland)
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy infants (birth weight greater than or equal to 2\.5 kg and Apgar score greater than or equal to 9 at 5 minutes) born at study sites
- •2\. Residing less than or equal to 50 km from study sites
- •3\. Family is not planning on travel during the study period (birth to 1 month)
Exclusion Criteria
- •1\. High risk newborns
- •2\. Other newborns requiring hospitalisation
- •3\. Birthweight less than 2\.5 kg
- •4\. Apgar score less than 9 at 5 minutes
- •5\. Infants residing more than 50 km from study sites
- •6\. Infants whose families are planning to be absent during one month study period
- •7\. A diagnosis or suspicion of B cell immunodeficiency in participant or immediate family
- •The study will not collect information on acquired immunodefiency disease or Human Immunodeficiency Virus (HIV) status of mother or study subject.
Outcomes
Primary Outcomes
Not specified
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