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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: Completed Phase 1 study, sponsored by Vaxart.

NCT04854746 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.

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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)

Primary Outcome

Safety

Interventions

  • BIOLOGICAL VXA-GI.1.NN
  • BIOLOGICAL Placebo Tablet

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2021-04-26
Est. Completion 2022-01-04
Phase Phase 1
Vaxart

19 total trials

What the finished NCT04854746 record still lists

NCT04854746 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 2 interventions - of which VXA-GI.1.NN is the first listed.

NCT04854746 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04854746'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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Source: ClinicalTrials.gov NCT04854746, the US trial registry maintained by the National Library of Medicine. NCT04854746 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.