Comparition of immunity and reaction of bOPV vaccine and tOPV vaccine in routine immunization schedule, with or without IPV vaccine administration at DTP3 vaccine contact: A controlled trial
- Registration Number
- CTRI/2013/06/003722
- Lead Sponsor
- World health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 900
1.Full term ( >37 weeks) healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital
2.Birth weight of >2.5 kg and Apgar score >9 at 5 min
3.Residing within a relatively short and easily accessible distance ( < 30 km)
4.Judged to be able to attend all scheduled study visits and comply with the study procedures
5.Parent or Legally Acceptable Representative (LAR) provides written informed consent or oral witnessed consent for the babyâ??s inclusion
1.Preterm (gestation age 37 weeks) baby or high risk delivery
2.Birth weight 2.5 kg or Apgar score at 5 min 9
3.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator
4.Residence 30 km from study site
5.Baby and the family expected not to be available for the study visits during the study period
6.Parent/LAR does not consent for their babyâ??s participation
7.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
8.Thrombocytopenia or a bleeding disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The seroconversion 28 days after 4 doses of bOPV compared to 4 doses of tOPV given in the routine immunization scheduleTimepoint: At Birth, cord blood sample collection <br/ ><br>Blood sample collection at 14 and 18 week in all 5 arms <br/ ><br>Stool sample collection at 18, 19 and 22 week in 4 arms and blood sample collection at 19 wk and 22 wk in one arm
- Secondary Outcome Measures
Name Time Method The secondary endpoints are <br/ ><br>â?¢Seroconversion after one dose of IPV added to the tOPV or bOPV at 14 weeks (DPT3 contact) in the EPI schedule <br/ ><br>â?¢Rapid boosting between 18 and 19 week visit to assess priming following the first dose of IPV (only in the bOPV and IPV arm) <br/ ><br>Rest in summary section <br/ ><br>Timepoint: At Birth, cord blood sample collection <br/ ><br>Blood sample collection at 14 and 18 week in all 5 arms <br/ ><br>Stool sample collection at 18, 19 and 22 week in 4 arms and blood sample collection at 19 wk and 22 wk in one arm <br/ ><br>