Immunogenicity nOPV2 With and Without bOPV (NCT04579510) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity nOPV2 With and Without bOPV
Bangladesh795 participantsStarted 2021-02-08
Plain-language summary
This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.
Who can participate
Age range42 Days – 48 Days
SexALL
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Inclusion Criteria:
* Healthy infants 6 weeks of age (range: 42-48 days).
* Parents that consent for participation in the full length of the study.
* Parents that can understand and comply with planned study procedures.
* Infant has at least one sibling aged \<10 years living in the same household that is eligible for participation in the study.
Exclusion Criteria:
* Parents and infants who are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
* A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
* A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or nOPV2 or collection of blood by venipuncture.
* Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
* Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
* Evidence of a chronic medical condition identified by a study medical officer during physical exam.
* Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
* Known allergy/sensitivity or reaction to polio vaccine, or its contents.
* Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vac…
What they're measuring
1
Vaccine response
Timeframe: Measured four weeks after administration of study vaccine(s).