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NCT02661490 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population

A Phase 2 study of Norovirus, sponsored by Takeda.

Completed
Registry status
Phase 2
Development phase
320
Enrollment target
10
Study locations

NCT02661490 is a Phase 2 study of Norovirus that has completed, run by Takeda. The registered enrollment target is 320 participants. The trial reports 10 study locations across 9 states.

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The verdict

NCT02661490, a Phase 2 study of Norovirus, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 2
Development phase
320 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.

Conditions Studied

Interventions

  • BIOLOGICAL Norovirus GI.1/GII.4 Bivalent VLP Vaccine
  • DRUG 0.9% sodium chloride (saline)

Study Locations (10)

New York

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

Alabama

  • Simon Williamson Clinic - Birmingham

Arizona

  • Fountain Hills Family Practice, P.C. - Fountain Hills

Colorado

  • Southwest Family Medicine - Littleton

Florida

  • Miami Research Associates - Miami

Kansas

  • Johnson County Clin-Trials - Lenexa

Missouri

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

Ohio

  • Cincinnati Childrens Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2016-02-01
Est. Completion 2017-09-29
Phase Phase 2

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT02661490

The ClinicalTrials.gov registry entry for NCT02661490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Norovirus appearing as the primary indexed condition, and to 2 interventions - of which Norovirus GI.1/GII.4 Bivalent VLP Vaccine is the first listed.

NCT02661490 reports 10 study locations spanning 9 distinct geographic areas - top geographies include New York, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT02661490 about?

NCT02661490 is a clinical study titled "Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population". The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.

What is the current status of trial NCT02661490?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2016-02-01. Estimated completion is 2017-09-29.

What conditions does trial NCT02661490 study?

This clinical trial studies the following conditions: Norovirus.

What interventions are being tested in trial NCT02661490?

The interventions under investigation include: Norovirus GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL), 0.9% sodium chloride (saline) (DRUG).

Who is sponsoring clinical trial NCT02661490?

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

Where is trial NCT02661490 being conducted?

This trial has 10 study locations across Alabama, Arizona, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.