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NCT01609257 · ClinicalTrials.gov registry record · Phase 1
Norovirus Bivalent-Vaccine Efficacy Study
A Phase 1 study of Prevention From Norovirus Infection, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 5
- Study locations
NCT01609257 is a Phase 1 study of Prevention From Norovirus Infection that has completed, run by Takeda. The registered enrollment target is 132 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT01609257, a Phase 1 study of Prevention From Norovirus Infection, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
Conditions Studied
Interventions
- BIOLOGICAL Norovirus Bivalent Vaccine
- BIOLOGICAL Saline Comparator
Study Locations (5)
Georgia
- Emory University - Atlanta
Maryland
- SNBL - Baltimore
New York
- University of Rochester - Rochester
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2012-07-16 |
| Est. Completion | 2014-03-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01609257
The ClinicalTrials.gov registry entry for NCT01609257 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prevention From Norovirus Infection appearing as the primary indexed condition, and to 2 interventions - of which Norovirus Bivalent Vaccine is the first listed.
NCT01609257 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Georgia, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT01609257 about?
NCT01609257 is a clinical study titled "Norovirus Bivalent-Vaccine Efficacy Study". The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
What is the current status of trial NCT01609257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2012-07-16. Estimated completion is 2014-03-18.
What conditions does trial NCT01609257 study?
This clinical trial studies the following conditions: Prevention From Norovirus Infection.
What interventions are being tested in trial NCT01609257?
The interventions under investigation include: Norovirus Bivalent Vaccine (BIOLOGICAL), Saline Comparator (BIOLOGICAL).
Who is sponsoring clinical trial NCT01609257?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01609257 being conducted?
This trial has 5 study locations across Georgia, Maryland, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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