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BIYELA - Bexsero Immunisation in Young Women in Africa

NCT06446752 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

  • Gonorrhea
  • Gonorrhea of Pharynx
  • Gonorrhea of Anus
  • Gonorrhea of Cervix

Interventions

BIOLOGICAL

Bexsero

Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).

BIOLOGICAL

Placebo

Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • University of Washington

    lead OTHER

Principal Investigators

  • Connie Celum, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2026-10-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446752 on ClinicalTrials.gov