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NCT00973284 · ClinicalTrials.gov registry record · Phase 1
Norwalk Vaccine Study
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00973284: Completed Phase 1 study, sponsored by Takeda.
NCT00973284 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00973284, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.
Primary Outcome
Viral AGE was a composite endpoint for the analysis of clinical illness and was defined as meeting one or more definitions of Norwalk Virus Infection and one or more of the definitions of AGE. Norwalk Virus Infection: * PAN-Immunoglobulin (Ig) Enzyme Linked Immunosorbent Assay (ELISA) for anti-Norwalk Virus Antibody IgM, IgG and IgA, ≥4-fold rise in titer in serum on Challenge Day 30 compared to Pre-Challenge. * Reverse Transcription Polymerase Chain Reaction (RT-PCR), a single positive post-c
Interventions
- BIOLOGICAL Norwalk VLP vaccine
- BIOLOGICAL mannitol and sucrose
- BIOLOGICAL Norwalk virus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2009-08-04 |
| Est. Completion | 2010-08-18 |
| Phase | Phase 1 |
What the finished NCT00973284 record still lists
NCT00973284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 3 interventions - of which Norwalk VLP vaccine is the first listed.
NCT00973284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00973284 about?
NCT00973284 is a clinical study titled "Norwalk Vaccine Study". The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.
What is the current status of trial NCT00973284?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2009-08-04. Estimated completion is 2010-08-18.
What interventions are being tested in trial NCT00973284?
The interventions under investigation include: Norwalk VLP vaccine (BIOLOGICAL), mannitol and sucrose (BIOLOGICAL), Norwalk virus (BIOLOGICAL).
Who is sponsoring clinical trial NCT00973284?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00973284's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 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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