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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 21 participants
Start Date 2006-02
Est. Completion 2008-08
Phase Phase 1

What the finished NCT00326443 record still lists

NCT00326443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00326443 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00326443's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT00326443, the US trial registry maintained by the National Library of Medicine. NCT00326443 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.