CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 320 enrolled
Drug / intervention
Norovirus GI.1/GII.4 Bivalent VLP Vaccine +2 morebiological
Likely dose
Not stated in 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/NCT02661490
NCT02661490Phase 2Completed
CompareCT.gov

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

Takeda·interventional·Posted Jan 22, 2016·Updated May 18, 2020

In Brief

A Phase 2 clinical trial evaluating Norovirus GI.1/GII.4 Bivalent VLP Vaccine and 0.9% sodium chloride (saline) for Norovirus. Completed, enrolled 320 participants across 10 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 22, 2016
Enrollment StartFeb 1, 2016
Primary CompletionOct 28, 2016
Study CompletionSep 29, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago

Interventions

Norovirus GI.1/GII.4 Bivalent VLP Vaccinebiological

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection

0.9% sodium chloride (saline)drug

norovirus bivalent placebo-matching vaccine

Norovirus GI.1/GII.4 Bivalent VLP Vaccinebiological

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with MPL and aluminum hydroxide for IM injection