Comparison of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine versus pre-qualified bivalent oral poliovirus vaccine: a randomized double-blind trial
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000591
- Lead Sponsor
- Panacea Biotec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 272
Inclusion Criteria
Infants between 6 weeks to 10 weeks of age born healthy (2.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance ( <30 km), and not planning to travel away during the entire study period (birth-1 months)
Exclusion Criteria
Newborns requiring hospitalization, birth weight below 2.50 kg, residence >30 km from study site, or families expecting to be absent during the 30-day study period. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Single dose of bOPV (from Sanofi Pasteur bulk) induces similar levels of seroconversion against poliovirus types 1 or 3, respectively than does one dose of bOPV (from PT BioFarma bulk)Timepoint: Sera collected at enrollment and 30 day visit, will be examined for the presence (detectable) or absence of neutralizing antibodies to type 1 and 3 poliovirus serotypes
- Secondary Outcome Measures
Name Time Method monitor adverse events following vaccine administrationTimepoint: follow up of 30 days post vaccination