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A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Sponsor: Fidec Corporation
Summary
The study will compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
Official title: A Phase III, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Key Details
Gender
All
Age Range
1 Day - 7 Days
Study Type
INTERVENTIONAL
Enrollment
740
Start Date
2025-12-08
Completion Date
2026-09-21
Last Updated
2025-07-24
Healthy Volunteers
Yes
Conditions
Interventions
nOPV2
nOPV2 will be administered at birth and Wk 14 of age depending on the study arm.
Locations (1)
icddr,b - Matlab Health Research Centre
Chāndpur, Dhaka Division, Bangladesh