â??Comparative evaluation of immunogenicity of bivalent oral poliovirus vaccine (bOPV) and monovalent oral poliovirus vaccine type 1 (mOPV1) with a dose of inactivated polio vaccine (IPV) at week 14

Phase 4

• Registration Number: CTRI/2016/04/006826
• Lead Sponsor: Panacea Biotec Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

1.Full term more then 37weeks healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital

2.Birth weight of ï?³ 2.5 kilograms

3.Apgar score ï?³ 9 at 5 minutes

4.Residing within a relatively short and easily accessible distance less then 30 km

5.Judged to be able to attend all scheduled study visits and comply with the study procedures

6.Parent or Legally Acceptable Representative provides written informed consent for the babyâ??s inclusion in the study

Exclusion Criteria

1.Not fulfilling any of the inclusion criteria

2.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator

3.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)

4.Thrombocytopenia or a bleeding disorder

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is seroconversion against polioviruses type-1, in bOPV and mOPV1 arms at week 18 (28 days after 4 doses of bOPV or mOPV1 administered in the EPI schedule along with a dose of IPV at week 14) and seroconversion against all three poliovirus types at week 18 after three doses of IPV given at 6, 10 & 14 weeks.Timepoint: At Birth, cord blood sample collection <br/ ><br>Blood sample collection at 14 and 18 week in all <br/ ><br>3 arms

Secondary Outcome Measures

Name	Time	Method
1.Seroconversion at week 14, four weeks after three doses of bOPV and mOPV1 (given at birth, 6, and 10 week) and 2 doses of IPV (given at 6 & 10 weeks) in the EPI schedule Seroconversion against polioviruses types 1, 2 & 3 at week 18, four weeks after 3 doses of IPV administered in the EPI schedule (6, 10 & 14 weeks) <br/ ><br>2.Seroconversion at week 22 against poliovirus types 1, 2 & 3, four weeks after the last IPV dose given at week 18 visitTimepoint: At Birth, cord blood sample collection <br/ ><br>Blood sample collection at 14 and 18 week in all <br/ ><br>3 arms