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NCT03039790 · ClinicalTrials.gov registry record · Phase 2

Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

A Phase 2 study of Healthy Volunteers and Norovirus, sponsored by Takeda.

Completed
Registry status
Phase 2
Development phase
528
Enrollment target
11
Study locations

NCT03039790 is a Phase 2 study of Healthy Volunteers and Norovirus that has completed, run by Takeda. The registered enrollment target is 528 participants, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (10% higher). The trial reports 11 study locations across 9 states.

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The verdict

NCT03039790, a Phase 2 study of Healthy Volunteers and Norovirus, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 2
Development phase
528 participants
Enrollment target
11
Study locations

Study Summary

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Conditions Studied

Healthy Volunteers Norovirus

Interventions

  • BIOLOGICAL NoV Vaccine

Study Locations (11)

New York

  • Regional Clinical Research Inc. - Endwell
  • University of Rochester - Rochester

Other

  • Universiteit Antwerpen - Antwerp
  • Universitair Ziekenhuis Gent - Ghent

Alabama

  • Simon-Williamson Clinic/Synexus Clinical Research US, Inc - Birmingham

Arizona

  • Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C. - Fountain Hills

Colorado

  • Synexus Clinical Research US, Inc/Southwest Family Medicine - Littleton

Florida

  • Miami Research Associates - Miami

Kansas

  • Johnson County Clin-Trials - Lenexa

Missouri

  • St. Louis University, School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 528 participants
Start Date 2017-02-21
Est. Completion 2021-07-22
Phase Phase 2

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT03039790

The ClinicalTrials.gov registry entry for NCT03039790 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 528 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (10% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which NoV Vaccine is the first listed.

NCT03039790 reports 11 study locations spanning 9 distinct geographic areas - top geographies include New York, Other, Alabama.

Frequently Asked Questions

What is clinical trial NCT03039790 about?

NCT03039790 is a clinical study titled "Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults". The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

What is the current status of trial NCT03039790?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 528 participants. The study started on 2017-02-21. Estimated completion is 2021-07-22.

What conditions does trial NCT03039790 study?

This clinical trial studies the following conditions: Healthy Volunteers, Norovirus.

What interventions are being tested in trial NCT03039790?

The interventions under investigation include: NoV Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03039790?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03039790 being conducted?

This trial has 11 study locations across Alabama, Arizona, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.