Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
Public ClinicalTrials.gov record NCT04350138. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04350138
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,606 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2020
- Primary completion
- Feb 17, 2026
- Completion
- Jul 7, 2026
- Last update posted
- Jul 23, 2026
2020 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - Infectious Disease | Birmingham | Alabama | 35294 | — |
| UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles | California | 90035 | — |
| SFDPH Bridge HIV Center | San Francisco | California | 94102 | — |
| Emory University School of Medicine - The Ponce de Leon Center | Atlanta | Georgia | 30303 | — |
| Emory University Hospital Midtown - Emory Clinic Infectious Diseases | Atlanta | Georgia | 30308 | — |
| University of Illinois at Chicago College of Medicine - Division of Infectious Diseases | Chicago | Illinois | 60612 | — |
| LSU - CrescentCare Sexual Health Center | New Orleans | Louisiana | 70119 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Harlem Prevention Center, Columbia University, Mailman School of Public Health | New York | New York | 10027 | — |
| University of Pennsylvania HIV/AIDS Prevention Research Division | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04350138, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04350138 live on ClinicalTrials.gov.