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NCT03897309 · ClinicalTrials.gov registry record · Phase 1
Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT03897309: Completed Phase 1 study, sponsored by Vaxart.
NCT03897309 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03897309, a Phase 1 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for \~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group \~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.
Primary Outcome
Comparison of rate of occurance and severity of Solicited Adverse Events observed between treatment groups
Interventions
- BIOLOGICAL VXA-G1.1-NN
- BIOLOGICAL VXA-G2.4-NS
- BIOLOGICAL Placebo Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 1 |
What the finished NCT03897309 record still lists
NCT03897309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 3 interventions - of which VXA-G1.1-NN is the first listed.
NCT03897309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03897309 about?
NCT03897309 is a clinical study titled "Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines". VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 i...
What is the current status of trial NCT03897309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2019-03-20. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT03897309?
The interventions under investigation include: VXA-G1.1-NN (BIOLOGICAL), VXA-G2.4-NS (BIOLOGICAL), Placebo Tablets (BIOLOGICAL).
Who is sponsoring clinical trial NCT03897309?
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 NCT03897309's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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