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Completed Phase 2 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT02661490

Public ClinicalTrials.gov record NCT02661490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II, Randomized, Double-blind, Safety and Immunogenicity Trial of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in Healthy Elderly Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02661490
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
320 participants

Conditions and interventions

Conditions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 1, 2016 (Actual)
Primary completion
Oct 28, 2016 (Actual)
Completion
Sep 29, 2017 (Actual)
Last update posted
May 18, 2020

2016 – 2017

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Simon Williamson Clinic Birmingham Alabama 35211 —
Fountain Hills Family Practice, P.C. Fountain Hills Arizona 85268 —
Southwest Family Medicine Littleton Colorado 80127 —
Miami Research Associates Miami Florida 33143 —
Johnson County Clin-Trials Lenexa Kansas 66219 —
St. Louis University, School of Medicine St Louis Missouri 63104 —
Regional Clinical Research Inc. Endwell New York 13760 —
University of Rochester Rochester New York 14642 —
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio 45229-3039 —
Group Health Research Institute Seattle Washington 98101 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02661490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2020 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02661490 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →