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

Comparative evaluation of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine (bOPV) and trivalent oral poliovirus vaccine (tOPV) in the standard EPI schedule, with or without inactivated polio vaccine (IPV) administration at DTP3 contact: A randomized controlled trial - WHO EPI Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003722

Enrollment

900

Registered

2013-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 1.Bivalent type 1 and 3 oral poliovirus vaccine (bOPV) containing at least 106 CCID50 of Sabin poliovirus type 1 and at least 105.8 CCID50 of Sabin poliovirus type 3 of Panacea Biotec L

Eligibility

Inclusion criteria

Inclusion criteria: 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 ( 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 Blood sample collection at 14 and 18 week in all 5 arms 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

Measure	Time frame
The secondary endpoints are â?¢Seroconversion after one dose of IPV added to the tOPV or bOPV at 14 weeks (DPT3 contact) in the EPI schedule 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) Rest in summary section Timepoint: At Birth, cord blood sample collection Blood sample collection at 14 and 18 week in all 5 arms 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	—

Measure

Time frame

The secondary endpoints are â?¢Seroconversion after one dose of IPV added to the tOPV or bOPV at 14 weeks (DPT3 contact) in the EPI schedule 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) Rest in summary section Timepoint: At Birth, cord blood sample collection Blood sample collection at 14 and 18 week in all 5 arms 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

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Countries

India

Contacts

Public ContactDr Arani Chatterjee

Panacea Biotec Ltd

aranichatterjee@panaceabiotec.com011-41679000

Outcome results