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NCT03576183 · ClinicalTrials.gov registry record · Phase 2

Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701

A Phase 2 study, sponsored by Valneva Austria.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT03576183: Completed Phase 2 study, sponsored by Valneva Austria.

NCT03576183 is a Phase 2 study that has completed, run by Valneva Austria. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03576183, a Phase 2 study, has completed, sponsored by Valneva Austria.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.

Primary Outcome

within 120 hours of challenge with ETEC strain LSN03-016011/A.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VLA1701
  • OTHER Challenge Strain

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2018-06-04
Est. Completion 2018-11-30
Phase Phase 2
Valneva Austria

11 total trials

What the finished NCT03576183 record still lists

NCT03576183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03576183 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03576183 about?

NCT03576183 is a clinical study titled "Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701". This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.

What is the current status of trial NCT03576183?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2018-06-04. Estimated completion is 2018-11-30.

What interventions are being tested in trial NCT03576183?

The interventions under investigation include: Placebo (BIOLOGICAL), VLA1701 (BIOLOGICAL), Challenge Strain (OTHER).

Who is sponsoring clinical trial NCT03576183?

This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03576183's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03576183, the US trial registry maintained by the National Library of Medicine. NCT03576183 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.