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NCT00269295 · ClinicalTrials.gov registry record · Phase 1
TY800 Dose Escalation (Typhoid)
A Phase 1 study of Typhoid and Paratyphoid Fevers, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT00269295 is a Phase 1 study of Typhoid and Paratyphoid Fevers that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 47 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00269295, a Phase 1 study of Typhoid and Paratyphoid Fevers, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine whether a new vaccine for typhoid fever is safe and effective. This study will also look at what effects (good and bad) this new vaccine, Ty800, has on the volunteers. The study will determine the highest dose of Ty800 that can be given without causing severe side effects. About 54 healthy males and females, ages 18-45 inclusive, in the Cincinnati metropolitan area will be enrolled in this study. They will be in the study for approximately 7 months, which includes a one month screening period, study product administration on Day 0, a 10-day hospital stay, an outpatient period on Days 9-28 with 4 follow-up visits, and safety follow-up phone calls at 2 and 6 months after hospital discharge. Researchers hope that this trial will help produce a vaccine that combines a high level of durable protective immunity with simplicity of administration and minimal reaction to the vaccine.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Ty800
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00269295
The ClinicalTrials.gov registry entry for NCT00269295 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 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 1 condition, with Typhoid and Paratyphoid Fevers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00269295 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00269295 about?
NCT00269295 is a clinical study titled "TY800 Dose Escalation (Typhoid)". The purpose of this research study is to determine whether a new vaccine for typhoid fever is safe and effective. This study will also look at what effects (good and bad) this new vaccine, Ty800, has on the volunteers. The study will determine the highest dose of Ty800 that can be given without caus...
What is the current status of trial NCT00269295?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2006-02. Estimated completion is 2007-01.
What conditions does trial NCT00269295 study?
This clinical trial studies the following conditions: Typhoid and Paratyphoid Fevers.
What interventions are being tested in trial NCT00269295?
The interventions under investigation include: Placebo (DRUG), Ty800 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00269295?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00269295 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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