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NCT03125473 · ClinicalTrials.gov registry record · Phase 1
Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT03125473: Completed Phase 1 study, sponsored by Vaxart.
NCT03125473 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03125473, a Phase 1 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers
Primary Outcome
Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).
Interventions
- BIOLOGICAL VXA-G1.1-NN Oral Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-04-07 |
| Est. Completion | 2018-05-06 |
| Phase | Phase 1 |
What the finished NCT03125473 record still lists
NCT03125473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 1 intervention - of which VXA-G1.1-NN Oral Vaccine is the first listed.
NCT03125473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03125473 about?
NCT03125473 is a clinical study titled "Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers". A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers
What is the current status of trial NCT03125473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2017-04-07. Estimated completion is 2018-05-06.
What interventions are being tested in trial NCT03125473?
The interventions under investigation include: VXA-G1.1-NN Oral Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03125473?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03125473's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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