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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: Completed Phase 1 study of Prevention From Norovirus Infection, sponsored by Takeda.
NCT01609257 is a Phase 1 study of Prevention From Norovirus Infection that has completed, run by Takeda. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitio
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 |
What the finished NCT01609257 record still lists
NCT01609257 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01609257's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 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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