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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults

ClinicalTrials.gov ID: NCT02142504

Public ClinicalTrials.gov record NCT02142504. 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, 1:51 PM EDT

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

Official title

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

Brief summary

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

The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs, Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from the trial.

Study identification

NCT ID
NCT02142504
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
454 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years to 49 Years
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
May 15, 2014 (Actual)
Primary completion
Jan 6, 2016 (Actual)
Completion
Jan 6, 2016 (Actual)
Last update posted
Aug 21, 2017

2014 – 2016

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
California Research Foundation San Diego California 92103-6204 —
Benchmark Research San Francisco San Francisco California 94108 —
Clin Research of South Florida Coral Gables Florida 33134 —
SNBL Baltimore Maryland 21201 —
St. Louis University, School of Medicine St Louis Missouri 63104 —
Rochester Clinical Research Rochester New York 14609 —
University of Rochester Rochester New York 14642 —
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio 45206 —
Benchmark Research Austin Austin Texas 78705 —
Baylor College of Medicine Houston Texas 77030-3498 —

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 NCT02142504, 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 Aug 21, 2017 · 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 NCT02142504 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →