A phase-IV randomised, double blind comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) versus trivalent OPV (tOPV): four-armed study
Completed
- Conditions
- PolioInfections and Infestations
- Registration Number
- ISRCTN54186735
- Lead Sponsor
- Panacea Biotec Limited (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 720
Inclusion Criteria
1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9)
2. Born at study sites (maternity hospitals)
3. Residing less than 30 km away from study site
4. Not planning to travel during entire study period (birth to 2 months)
Exclusion Criteria
1. Newborns requiring hospitalisation
2. Birth weight less than 2.5 kg
3. Apgar score at 5 minutes less than 9
4. Residence greater than 30 km from study sites
5. Families expecting to be absent during the 60 day study period
6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroconversion 30 days after a single dose of tOPV or mOPV1.
- Secondary Outcome Measures
Name Time Method Seroconversion after two doses of vaccine (one of three mOPV1 vaccines and tOPV).