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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 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 86 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03897309
The ClinicalTrials.gov registry entry for NCT03897309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaxart, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which VXA-G1.1-NN is the first listed.
NCT03897309 reports 0 study locations.
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.
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