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NCT01688297 · ClinicalTrials.gov registry record · Phase 1

Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

A Phase 1 study, sponsored by Vaxart.

Completed
Registry status
Phase 1
Development phase
61
Enrollment target

NCT01688297: Completed Phase 1 study, sponsored by Vaxart.

NCT01688297 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01688297, a Phase 1 study, has completed, sponsored by Vaxart.

COMPLETED
Registry status
Phase 1
Development phase
61 participants
Enrollment target

Study Summary

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Interventions

  • BIOLOGICAL VXA-A1.1 Oral Vaccine
  • BIOLOGICAL VXA Placebo Tablet

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2012-09
Est. Completion 2015-04
Phase Phase 1
Vaxart

19 total trials

What the finished NCT01688297 record still lists

NCT01688297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which VXA-A1.1 Oral Vaccine is the first listed.

NCT01688297 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01688297 about?

NCT01688297 is a clinical study titled "Safety Study of an Oral Vaccine to Prevent Seasonal Influenza". The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two...

What is the current status of trial NCT01688297?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-09. Estimated completion is 2015-04.

What interventions are being tested in trial NCT01688297?

The interventions under investigation include: VXA-A1.1 Oral Vaccine (BIOLOGICAL), VXA Placebo Tablet (BIOLOGICAL).

Who is sponsoring clinical trial NCT01688297?

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

How this trial's enrollment target compares

Where NCT01688297's enrollment target sits among peer trials

61 828th of 2000 higher than 1,170 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 NCT01688297, the US trial registry maintained by the National Library of Medicine. NCT01688297 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.