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Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
NCT04350138 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Population. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Meningococcal Group B Vaccine
Study Locations (13)
California
- UCLA Clinical AIDS Research and Education (CARE) Center — Los Angeles
- SFDPH Bridge HIV Center — San Francisco
Georgia
- Emory University School of Medicine - The Ponce de Leon Center — Atlanta
- Emory University Hospital Midtown - Emory Clinic Infectious Diseases — Atlanta
Other
- The Thai Red Cross AIDS Research Centre — Bangkok
- Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research Center — Bangkok
Alabama
- University of Alabama at Birmingham School of Medicine - Infectious Disease — Birmingham
Illinois
- University of Illinois at Chicago College of Medicine - Division of Infectious Diseases — Chicago
Louisiana
- LSU - CrescentCare Sexual Health Center — New Orleans
Maryland
- Walter Reed National Military Medical Center — Bethesda
New York
- Harlem Prevention Center, Columbia University, Mailman School of Public Health — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,606 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04350138
The ClinicalTrials.gov registry entry for NCT04350138 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Gonococcal Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04350138 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, Georgia, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04350138 about?
NCT04350138 is a clinical study titled "Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection". This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participant...
What is the current status of trial NCT04350138?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 2,606 participants. The study started on 2020-12-29. Estimated completion is 2026-10-01.
What conditions does trial NCT04350138 study?
This clinical trial studies the following conditions: Gonococcal Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04350138?
The interventions under investigation include: Placebo (OTHER), Meningococcal Group B Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04350138?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04350138 being conducted?
This trial has 13 study locations across Alabama, California, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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