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NOT YET RECRUITING
NCT07010822
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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