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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.

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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

FieldValue
Enrollment Target 11 participants
Start Date 2019-10-09
Est. Completion 2020-09-01
Phase Phase 4

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.