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NCT04854746 · ClinicalTrials.gov registry record · Phase 1
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT04854746 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 66 participants.
The verdict
NCT04854746, 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, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
Interventions
- BIOLOGICAL VXA-GI.1.NN
- BIOLOGICAL Placebo Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2022-01-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04854746
The ClinicalTrials.gov registry entry for NCT04854746 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 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 2 interventions - of which VXA-GI.1.NN is the first listed.
NCT04854746 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04854746 about?
NCT04854746 is a clinical study titled "Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine". A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess th...
What is the current status of trial NCT04854746?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2021-04-26. Estimated completion is 2022-01-04.
What interventions are being tested in trial NCT04854746?
The interventions under investigation include: VXA-GI.1.NN (BIOLOGICAL), Placebo Tablet (BIOLOGICAL).
Who is sponsoring clinical trial NCT04854746?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
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