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Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

StatusRecruiting
PhasePhase 1/2
SponsorPATH
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Nov 10, 2024 to Nov 20, 2024
    v4
  2. Start date: Mar 29, 2025 to Nov 10, 2024
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 115 words
    • Site contact updated
    v3
  3. Primary and study completion dates: Dec 15, 2025 to Dec 15, 2027
    • Start date: Dec 29, 2023 to Mar 29, 2025
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 main objectives of this study are to : * evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Trial Details
NCT Number NCT06137664
Lead Sponsor PATH
Collaborators: Bio Farma, Indonesia
Conditions
(from sponsor)		 Poliomyelitis
Related terms Poliomyelitis
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov