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A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women
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.
Details
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 1100 |
| Start date | 2024-08-14 |
| Completion | 2027-01 |
Conditions
- Gonorrhea
- Gonorrhea of Pharynx
- Gonorrhea of Anus
- Gonorrhea of Cervix
Interventions
- Bexsero
- Placebo
Primary outcomes
- First diagnosis of gonorrhea at cervical or anorectal sites occurring greater than or equal to 1 month after the second vaccination with study product through to the study end — 18 months
Assess efficacy of Bexsero in prevention of cervical and/or anorectal gonococcal infection
Countries
South Africa