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BIYELA - Bexsero Immunisation in Young Women in Africa

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 5 of 5 sites · Publications: details revised at 19 of 19 entriesv4 Show 2 more changesShow less
    • Site details revised at 5 of 5 sites
    • Publications: details revised at 19 of 19 entries
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 31, 2026 to Oct 2026 · Completion date: Aug 2026 to Jan 2027 · Start date changed from estimate of Aug 2024 to Aug 14, 2024 · 2 morev3 Show 5 more changesShow less
    • Primary completion date: May 31, 2026 to Oct 2026
    • Completion date: Aug 2026 to Jan 2027
    • Start date changed from estimate of Aug 2024 to Aug 14, 2024
    • Site details revised at 5 of 5 sites
    • Publications: details revised at 19 of 19 entries
  3. Start date: Jun 2024 to Aug 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This proposed 2-arm randomized evaluation of two doses of 4CMenB vaccine versus placebo at Enrollment and Month 2 is designed as a proof-of-concept study to inform potential use for dual meningococcal B and gonococcal prevention, and to inform Neisseria gonorrheae vaccine development.
Trial Details
NCT Number NCT06446752
Lead Sponsor University of Washington
Collaborators: Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa
Conditions Gonorrhea, Gonorrhea of Pharynx, Gonorrhea of Anus, Gonorrhea of Cervix
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov