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NCT02473224 · ClinicalTrials.gov registry record · Phase 1
Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies
A Phase 1 study of Gastroenteritis Norovirus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT02473224 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 44 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02473224, 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
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2) determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion (= / \> 75%) of subjects.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Norovirus GII.2 Challenge
Study Locations (1)
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-10-28 |
| Est. Completion | 2018-11-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02473224
The ClinicalTrials.gov registry entry for NCT02473224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 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.
NCT02473224 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT02473224 about?
NCT02473224 is a clinical study titled "Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies". This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The study dura...
What is the current status of trial NCT02473224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2015-10-28. Estimated completion is 2018-11-27.
What conditions does trial NCT02473224 study?
This clinical trial studies the following conditions: Gastroenteritis Norovirus.
What interventions are being tested in trial NCT02473224?
The interventions under investigation include: Placebo (OTHER), Norovirus GII.2 Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT02473224?
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 NCT02473224 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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