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RECRUITING
NCT05644184
PHASE2

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Sponsor: PATH

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).

Official title: A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh

Key Details

Gender

All

Age Range

0 Days - 4 Years

Study Type

INTERVENTIONAL

Enrollment

2232

Start Date

2023-03-27

Completion Date

2026-05-15

Last Updated

2026-01-09

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)

Drop counts of nOPV vaccine will be varied to achieve approximately 10\^5.5, 10\^6.0, 10\^6.5 CCID50 or 10\^7.0, 10\^7.5 dose levels.

BIOLOGICAL

Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)

The Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 control and challenge vaccine (mOPV1) contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh