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NCT03039790 · ClinicalTrials.gov registry record · Phase 2
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
A Phase 2 study of Healthy Volunteers and Norovirus, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 528
- Enrollment target
- 11
- Study locations
NCT03039790: Completed Phase 2 study of Healthy Volunteers and Norovirus, sponsored by Takeda.
NCT03039790 is a Phase 2 study of Healthy Volunteers and Norovirus that has completed, run by Takeda. The registered enrollment target is 528 participants, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (10% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03039790, a Phase 2 study of Healthy Volunteers and Norovirus, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 528 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.
Primary Outcome
GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)
Conditions Studied
Interventions
- BIOLOGICAL NoV Vaccine
Study Locations (11)
New York
- Regional Clinical Research Inc. - Endwell
- University of Rochester - Rochester
Other
- Universiteit Antwerpen - Antwerp
- Universitair Ziekenhuis Gent - Ghent
Alabama
- Simon-Williamson Clinic/Synexus Clinical Research US, Inc - Birmingham
Arizona
- Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C. - Fountain Hills
Colorado
- Synexus Clinical Research US, Inc/Southwest Family Medicine - Littleton
Florida
- Miami Research Associates - Miami
Kansas
- Johnson County Clin-Trials - Lenexa
Missouri
- St. Louis University, School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 2 |
What the finished NCT03039790 record still lists
NCT03039790 is an interventional study that assigns participants to a tested intervention. The registered 528 participants enrollment target is mid-sized for trials with a published cap, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (10% higher).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which NoV Vaccine is the first listed.
NCT03039790 lists 11 locations in 9 states (New York, Other, Alabama).
Frequently Asked Questions
What is clinical trial NCT03039790 about?
NCT03039790 is a clinical study titled "Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults". The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.
What is the current status of trial NCT03039790?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 528 participants. The study started on 2017-02-21. Estimated completion is 2021-07-22.
What conditions does trial NCT03039790 study?
This clinical trial studies the following conditions: Healthy Volunteers, Norovirus.
What interventions are being tested in trial NCT03039790?
The interventions under investigation include: NoV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03039790?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03039790 being conducted?
This trial has 11 study locations across Alabama, Arizona, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03039790's enrollment target sits among peer trials
528 29th of 283 higher than 255 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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