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

â??Comparative evaluation of immunogenicity of bivalent oral poliovirus vaccine (bOPV) and monovalent oral poliovirus vaccine type 1 (mOPV1) when administered in the EPI schedule with a dose of inactivated polio vaccine (IPV) at week 14 and assessment of immunogenicity of IPV only schedule in the EPI: A multicentric open label randomized controlled trialâ?? - WHO mOPV1 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/04/006826

Enrollment

600

Registered

2016-04-18

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: Monovalent oral poliovirus vaccine type 1 (mOPV1) : 4 doses of 2 drops oral mOPV1 will be administered at birth,6,10,14 weeks Intervention2: Inactivated poliovirus vaccine (IPV): 0.5

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Blood sample collection at 14 and 18 week in all 3 arms	—

Measure

Time frame

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 Blood sample collection at 14 and 18 week in all 3 arms

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Secondary

Measure	Time frame
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) 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 Blood sample collection at 14 and 18 week in all 3 arms	—

Measure

Time frame

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) 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 Blood sample collection at 14 and 18 week in all 3 arms

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Countries

India

Contacts

Public ContactDr Lalitendu Mohanty

Panacea Biotec Ltd

lalitendumohanty@panaceabiotec.com9811923256

Outcome results