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NCT02669121 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults

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

Completed
Registry status
Phase 2
Development phase
4,748
Enrollment target
1
Study location

NCT02669121 is a Phase 2 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 4,748 participants, above the 465-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (921% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT02669121, a Phase 2 study of Healthy Volunteers, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 2
Development phase
4,748 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.

Conditions Studied

Healthy Volunteers

Interventions

  • BIOLOGICAL NoV Placebo-matching Saline
  • BIOLOGICAL NoV GI.1/GII.4 Bivalent VLP Vaccine

Study Locations (1)

Illinois

  • Great Lakes Naval Station - Great Lakes

Trial Details

FieldValue
Enrollment Target 4,748 participants
Start Date 2016-06-14
Est. Completion 2018-06-16
Phase Phase 2

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT02669121

The ClinicalTrials.gov registry entry for NCT02669121 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4,748 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 465-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (921% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which NoV Placebo-matching Saline is the first listed.

NCT02669121 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT02669121 about?

NCT02669121 is a clinical study titled "Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults". The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.

What is the current status of trial NCT02669121?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 4,748 participants. The study started on 2016-06-14. Estimated completion is 2018-06-16.

What conditions does trial NCT02669121 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT02669121?

The interventions under investigation include: NoV Placebo-matching Saline (BIOLOGICAL), NoV GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02669121?

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

Where is trial NCT02669121 being conducted?

This trial has 1 study location across Illinois. 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.