Clinical Trial

Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama

Recruiting Phase 2
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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 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-12-14; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Recruiting 2023-12-01
Trial Details
NCT Number NCT05654467
Lead Sponsor PATH
Collaborators: Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, Technical Resources International, Inc.
Conditions Poliomyelitis
Enrollment 1,532 participants
Start Date 2023-12-05
Primary Completion 2027-03-20 (estimated)
Study Completion 2027-03-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-11