Status:
UNKNOWN
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Centers for Disease Control and Prevention
Government of Bangladesh
Conditions:
Polio
Eligibility:
All Genders
42-48 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV: 1. Addition of IPV after one or several doses of...
Detailed Description
The study will assess whether adding IPV at the end of a 3-dose series of co-administered nOPV2+bOPV achieves at least a 95% seroconversion to all serotypes and whether adding IPV following two doses ...
Eligibility Criteria
Inclusion
- Healthy infants 6 weeks of age
- Parents that consent for participation in the full length of the study.
- Parents that can understand and comply with planned study procedures.
Exclusion
- Parents and infants are unable to participate in the full length of the study
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder
- Acute diarrhoea, infection, or illness at the time of enrolment
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
- Evidence of a chronic medical condition
- Receipt of any polio vaccine (OPV or IPV) before enrolment
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births.
- Infants from premature births (\<37 weeks of gestation).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT06114810
Start Date
November 1 2023
End Date
September 1 2024
Last Update
November 7 2023
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