Clinical Trial

BIYELA - Bexsero Immunisation in Young Women in Africa

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-04; most recent amendment 2025-07-07.
Status change: Recruiting → Active, Not Recruiting 2025-07-07
Status change: Not Yet Recruiting → Recruiting 2025-03-24
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 2024-08-14
Primary Completion 2026-10 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-10