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NCT00396370 · ClinicalTrials.gov registry record · Phase 1
BCG Vaccination Delivered Intradermally, Orally and by Combined Routes
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00396370: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00396370 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396370, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will be given by mouth and/or by injection into the skin. This study, conducted at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study procedures will include a physical exam; review of TB exposure history and medical history; collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and blood tests for TB. Volunteers may participate for about 24 months.
Interventions
- OTHER Placebo
- BIOLOGICAL BCG strain Connaught
- BIOLOGICAL BCG strain Danish
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2008-12-02 |
| Est. Completion | 2012-07-23 |
| Phase | Phase 1 |
What the finished NCT00396370 record still lists
NCT00396370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00396370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00396370 about?
NCT00396370 is a clinical study titled "BCG Vaccination Delivered Intradermally, Orally and by Combined Routes". This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will be given by mouth and...
What is the current status of trial NCT00396370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2008-12-02. Estimated completion is 2012-07-23.
What interventions are being tested in trial NCT00396370?
The interventions under investigation include: Placebo (OTHER), BCG strain Connaught (BIOLOGICAL), BCG strain Danish (BIOLOGICAL).
Who is sponsoring clinical trial NCT00396370?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00396370's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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