At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 4,748 enrolled

Drug / intervention

NoV Placebo-matching Saline +1 morebiological

Likely dose

NoV GI.1/GII.4 Bivalent VLP Vaccine 500 µgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02669121

NCT02669121Phase 2Completed

Compare CT.gov

Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years

Takeda·interventional·Posted Jan 29, 2016·Updated Jun 10, 2021

In Brief

A Phase 2 clinical trial evaluating NoV Placebo-matching Saline and NoV GI.1/GII.4 Bivalent VLP Vaccine for Healthy Volunteers. Completed, enrolled 4,748 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy Volunteers

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedJan 2016

Enrollment StartJun 2016

Primary CompletionJun 2018

TodayJul 2026

First PostedJan 29, 2016

Enrollment StartJun 14, 2016

Primary CompletionJun 16, 2018

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 10.4 years ago

Interventions

NoV Placebo-matching Salinebiological

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

NoV GI.1/GII.4 Bivalent VLP Vaccinebiological

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