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NCT00326443 · ClinicalTrials.gov registry record · Phase 1
CVD 909 Vi Prime Boost Study
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00326443 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 21 participants.
The verdict
NCT00326443, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.
Interventions
- DRUG Placebo
- BIOLOGICAL CVD 909
- BIOLOGICAL Vi Polysaccharide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326443
The ClinicalTrials.gov registry entry for NCT00326443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00326443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00326443 about?
NCT00326443 is a clinical study titled "CVD 909 Vi Prime Boost Study". The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi ...
What is the current status of trial NCT00326443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2006-02. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00326443?
The interventions under investigation include: Placebo (DRUG), CVD 909 (BIOLOGICAL), Vi Polysaccharide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00326443?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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