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NCT04094883 · ClinicalTrials.gov registry record · Phase 4
Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT04094883: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT04094883 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04094883, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea. Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant, HIV negative, have no history of congenital immunologic disorder, and are not taking immune suppressive medications will be enrolled on this study at a single site, University of North Carolina at Chapel Hill (UNC-CH). Procedures (methods): Participants will receive two-doses of an FDA-approved vaccine that provides protection from N. meningitidis infection according to the recommended dosing schedule. The first vaccine dose will be given to participants at the entry visit and the second vaccine dose will be given to participants at the week 5 visit. The participants will provide samples of blood as well as mucosal surface derived samples (urine and/or swabs) at four separate visits (entry, week 5, week 6, and week 7).
Primary Outcome
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
Interventions
- BIOLOGICAL Meningococcal Group B Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2020-09-01 |
| Phase | Phase 4 |
What the finished NCT04094883 record still lists
NCT04094883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Meningococcal Group B Vaccine is the first listed.
NCT04094883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04094883 about?
NCT04094883 is a clinical study titled "Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine". The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea. Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant, HIV negative, have no history of congen...
What is the current status of trial NCT04094883?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2019-10-09. Estimated completion is 2020-09-01.
What interventions are being tested in trial NCT04094883?
The interventions under investigation include: Meningococcal Group B Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04094883?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04094883's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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