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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

NCT06446752 Phase 3 ACTIVE_NOT_RECRUITING

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 sponsorUniversity of Washington
PhasePhase 3
StatusACTIVE_NOT_RECRUITING
Enrolment1100
Start date2024-08-14
Completion2027-01

Conditions

Interventions

Primary outcomes

Countries

South Africa