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Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama

StatusRecruiting
PhasePhase 2
SponsorPATH
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Nov 20, 2025 to Mar 20, 2027v7
  2. Primary and study completion dates: Aug 28, 2025 to Nov 20, 2025
    • Start date changed from estimate of Dec 4, 2023 to Dec 5, 2023
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v5
  4. Primary completion date: Jan 31, 2024 to Aug 28, 2025
    • Start date: Oct 6, 2023 to Dec 4, 2023
    • Study completion date: May 31, 2024 to Aug 28, 2025
    v4
  5. Start date: Aug 28, 2023 to Oct 6, 2023
    • Study completion date: Jan 31, 2024 to May 31, 2024
    v3
  6. Start date: May 29, 2023 to Aug 28, 2023
    • Study sites: 4 to 3
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PATH
7 trials monitored
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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).
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
(from sponsor)		 Poliomyelitis
Related terms Poliomyelitis
Enrollment 1,532 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov