CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 454 enrolled
Drug / intervention
Norovirus Bivalent VLP Vaccine +1 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/NCT02142504
NCT02142504Phase 2Completed
CompareCT.gov

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

Takeda·interventional·Posted May 20, 2014·Updated Aug 21, 2017

In Brief

A Phase 2 clinical trial evaluating Norovirus Bivalent VLP Vaccine and Placebo (Saline) for Norovirus Prevention. Completed, enrolled 454 participants across 10 sites.

Detailed Summary

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 Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 20, 2014
Enrollment StartMay 15, 2014
Primary CompletionJan 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago

Interventions

Norovirus Bivalent VLP Vaccinebiological

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

Placebo (Saline)drug

Placebo-matching norovirus bivalent VLP vaccine