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NCT03121339 · ClinicalTrials.gov registry record · Phase 1

Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults

A Phase 1 study, sponsored by Vaxart.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT03121339: Completed Phase 1 study, sponsored by Vaxart.

NCT03121339 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03121339, a Phase 1 study, has completed, sponsored by Vaxart.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.

Primary Outcome

Site of initial and complete disintegration of the study DP

Interventions

  • BIOLOGICAL VXA-A1.1 H1 Tablet Vaccine (small)
  • BIOLOGICAL VXA-A1.1 H1 Tablet Vaccine (large)

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2017-03-31
Est. Completion 2018-04-03
Phase Phase 1
Vaxart

19 total trials

What the finished NCT03121339 record still lists

NCT03121339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which VXA-A1.1 H1 Tablet Vaccine (small) is the first listed.

NCT03121339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03121339 about?

NCT03121339 is a clinical study titled "Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults". This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasti...

What is the current status of trial NCT03121339?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2017-03-31. Estimated completion is 2018-04-03.

What interventions are being tested in trial NCT03121339?

The interventions under investigation include: VXA-A1.1 H1 Tablet Vaccine (small) (BIOLOGICAL), VXA-A1.1 H1 Tablet Vaccine (large) (BIOLOGICAL).

Who is sponsoring clinical trial NCT03121339?

This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03121339's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 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 NCT03121339, the US trial registry maintained by the National Library of Medicine. NCT03121339 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.