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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 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 11 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04094883
The ClinicalTrials.gov registry entry for NCT04094883 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Meningococcal Group B Vaccine is the first listed.
NCT04094883 reports 0 study locations.
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.
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