At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bexsero and Placebo for Gonorrhea and 3 related conditions. Active but no longer recruiting, targeting 1,100 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).
Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).