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10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 90 participants (planned 126) · Primary completion date changed from estimate of Mar 2026 to Jun 24, 2025 · Study completion date changed from estimate of Mar 2026 to Dec 9, 2025 · 3 more Show 6 more changesShow less
    • Final enrollment: 90 participants (planned 126)
    • Primary completion date changed from estimate of Mar 2026 to Jun 24, 2025
    • Study completion date changed from estimate of Mar 2026 to Dec 9, 2025
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 6 of 14 entries
    • Site details revised at 2 of 2 sites
  2. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 90 to 126 · Study sites: 0 to 2 · Start date changed from estimate of Mar 2025 to May 13, 2025v2 Show 3 more changesShow less
    • Enrollment target: 90 to 126
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2025 to May 13, 2025
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).
Trial Details
NCT Number NCT06803524
Lead Sponsor Mahidol University
Collaborators: BioNet-Asia Co., Ltd.
Conditions Pertussis
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov