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Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

StatusCompleted
PhasePhase 2
SponsorPATH
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of May 15, 2026 to Sep 22, 2026
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description revised
    • Site details revised
  2. Enrollment target: 2012 to 2232
    • Secondary endpoints revised (9)
    • Study description revised
    v6
  3. Primary and study completion dates: Feb 2025 to May 15, 2026v5 Show 5 more changesShow less
    • Enrollment target: 1683 to 2012
    • Eligibility criteria expanded, about 244 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 8 words
    • Study arms: 12 to 15
  4. Primary and study completion dates: Jun 2024 to Feb 2025v4
  5. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Feb 2023 to Mar 27, 2023
    • Site contact updated
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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).
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
(from sponsor)		 Poliomyelitis
Related terms Poliomyelitis
Enrollment 2,232 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov