Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03125473 · ClinicalTrials.gov registry record · Phase 1

Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers

A Phase 1 study, sponsored by Vaxart.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT03125473: Completed Phase 1 study, sponsored by Vaxart.

NCT03125473 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.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03125473, 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, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers

Primary Outcome

Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).

Interventions

  • BIOLOGICAL VXA-G1.1-NN Oral Vaccine

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2017-04-07
Est. Completion 2018-05-06
Phase Phase 1
Vaxart

19 total trials

What the finished NCT03125473 record still lists

NCT03125473 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 1 intervention - of which VXA-G1.1-NN Oral Vaccine is the first listed.

NCT03125473 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03125473 about?

NCT03125473 is a clinical study titled "Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers". A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers

What is the current status of trial NCT03125473?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2017-04-07. Estimated completion is 2018-05-06.

What interventions are being tested in trial NCT03125473?

The interventions under investigation include: VXA-G1.1-NN Oral Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03125473?

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

How this trial's enrollment target compares

Where NCT03125473'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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02584244 · 66 participants · Phase 1

    Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

  • NCT03067051 · 66 participants · Phase 1

    Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

  • NCT03754725 · 66 participants · Phase 1

    Ferritin and Iron Burden in SAH sIRB

  • NCT03875378 · 66 participants · Phase 2

    Transdermal Estrogen in Women With Anorexia Nervosa

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03125473, the US trial registry maintained by the National Library of Medicine. NCT03125473 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.