CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 840 enrolled
Drug / intervention
GI.1/GII.4 (15/15) +4 morebiological
Likely dose
GI.1/GII.4 (15/15) 15 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/NCT02153112
NCT02153112Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Combined With Aluminum Hydroxide Adjuvant in Children, Toddlers, and Infants

Takeda·interventional·Posted Jun 2, 2014·Updated Apr 1, 2019

In Brief

A Phase 2 clinical trial evaluating GI.1/GII.4 (15/15), GI.1/GII.4 (15/50), and 3 other interventions for Norovirus. Completed, enrolled 840 participants across 12 sites in 3 countries.

Detailed Summary

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus
CountriesColombia, Finland, Panama
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2, 2014
Enrollment StartJun 23, 2015
Primary CompletionJun 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.1 years ago

Interventions

GI.1/GII.4 (15/15)biological

Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

GI.1/GII.4 (15/50)biological

Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

GI.1/GII.4 (50/50)biological

Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

GI.1/GII.4 (50/150)biological

Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

Placebodrug

Placebo saline solution