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
- Conditions
- PoliomyelitisInfections and Infestations
- Registration Number
- ISRCTN18107202
- Lead Sponsor
- World Health Organization (WHO) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 800
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroconversion 30 days after a single dose of tOPV, mOPV1, or mOPV3. Measurements on humoral immunity (specific primary endpoints) as as follows:<br>1. One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than one dose of tOPV<br>2. One dose of mOPV3 induces significantly higher levels of seroconversion against poliovirus type 3 than one dose of tOPV
- Secondary Outcome Measures
Name Time Method o secondary outcome measures