MedTrace Logo

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

NCT02669121 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4748

Last updated 2021-06-10

Study results available
· View outcomes & findings →

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

  • Healthy Volunteers

Interventions

BIOLOGICAL

NoV Placebo-matching Saline

NoV placebo-matching saline (0.9% sodium chloride).

BIOLOGICAL

NoV GI.1/GII.4 Bivalent VLP Vaccine

NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-14
Primary Completion
2018-06-16
Completion
2018-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669121 on ClinicalTrials.gov