A randomized, open label, multicenter study to evaluate the immunogenicity and safety of BBILs trivalent type 1, 2 & 3 oral polio vaccine
- Registration Number
- CTRI/2015/06/005856
- Lead Sponsor
- Bharath biotech Int Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Written and signed informed consent by subject parents or legally acceptable guardian.
Healthy male or female full term neonate aged less than three hours at time of enrollment.
The delivery was not high-risk
The APGAR score was greater than 7 when measure 1 minute after birth
Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion.
Family does not plan to move during the study period, and housed not further that 50km away from the study site.
Fever of any origin or infections.
Any confirmed or suspected immunosuppressive condition.
Any treatment with immunosuppressive or Immuno stimulant therapy
Use of any marketed or investigational medicine or non-registered drug or vaccine for polio.
Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and demonstrate that the Immunogenicity of the investigational product BIOPOLIO is not clinically inferior to that of WHO pre-qualified Trivalent OPV vaccine. To assess the antibodies titers for type 1, 2 & 3 poliovirus after two doses of trivalent oral polio. <br/ ><br> <br/ ><br>a)Seroconversion; A fourfold rise in antibody titer of type 1, 2 & 3 polio virus from baseline pre- vaccination titers and 14±2 days after second dose of vaccination. <br/ ><br>Timepoint: Baseline (Day 0) <br/ ><br>14 days after second dose of vaccination(Day 44)
- Secondary Outcome Measures
Name Time Method to evaluate the safety, local and systemic reaction of two doses of BIOPOLIO OPV vaccine as compared to WHO pre-qualified Trivalent OPV vaccine administered as two doses, given 30±2 days apart. <br/ ><br>Timepoint: 2 years