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NCT04453293 · ClinicalTrials.gov registry record · Phase 3
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
A Phase 3 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Terminated
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT04453293 is a Phase 3 study that was terminated before completion, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 16 participants.
The verdict
NCT04453293, a Phase 3 study, was terminated before completion, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled.
Interventions
- DRUG Placebo
- BIOLOGICAL BCG (Tokyo 172) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04453293
The ClinicalTrials.gov registry entry for NCT04453293 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04453293 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04453293 about?
NCT04453293 is a clinical study titled "Immunization With BCG Vaccine to Prevent Tuberculosis Infection". The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive va...
What is the current status of trial NCT04453293?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2021-12-01. Estimated completion is 2026-01-16.
What interventions are being tested in trial NCT04453293?
The interventions under investigation include: Placebo (DRUG), BCG (Tokyo 172) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04453293?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
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