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NCT00138476 · ClinicalTrials.gov registry record · Phase 1
New Challenge Pool of Norwalk Virus Inoculum
A Phase 1 study of Gastroenteritis Norovirus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT00138476 is a Phase 1 study of Gastroenteritis Norovirus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 57 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00138476, a Phase 1 study of Gastroenteritis Norovirus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea. If this NV preparation is shown to cause Norwalk illness, then it can be used to test new vaccines in the future. Additionally, researchers hope to determine the lowest dose of NV inoculum that can be given to volunteers and cause illness. Study participants will include 57 healthy adults, ages 18-50. Participants will either be given the NV inoculum or placebo (water without virus). Participants will be hospitalized for a maximum of 7 days and a minimum of 4 days following the NV challenge. Study procedures include physical exam, blood testing, and collection of saliva, urine, and stool samples. Participants will be involved in study related procedures for up to 180 days.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Norwalk Virus
Study Locations (1)
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2004-08 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138476
The ClinicalTrials.gov registry entry for NCT00138476 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 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 Gastroenteritis Norovirus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00138476 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00138476 about?
NCT00138476 is a clinical study titled "New Challenge Pool of Norwalk Virus Inoculum". The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea. If this NV preparation is shown to cause Norwalk illness, then it can be used to test new vaccines in the future. Additiona...
What is the current status of trial NCT00138476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2004-08. Estimated completion is 2012-09.
What conditions does trial NCT00138476 study?
This clinical trial studies the following conditions: Gastroenteritis Norovirus.
What interventions are being tested in trial NCT00138476?
The interventions under investigation include: Placebo (DRUG), Norwalk Virus (BIOLOGICAL).
Who is sponsoring clinical trial NCT00138476?
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 NCT00138476 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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