Clinical Trial

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated January 9, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-11-30; most recent amendment 2026-01-07.
Status change: Enrolling by Invitation → Recruiting 2023-05-26
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-05-10
Trial Details
NCT Number NCT05644184
Lead Sponsor PATH
Collaborators: Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, DiagnoSearch Life Sciences Pvt. Ltd.
Conditions Poliomyelitis
Enrollment 2,232 participants
Start Date 2023-03-27
Primary Completion 2026-05-15 (estimated)
Study Completion 2026-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-09