At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 420 enrolled
Drug / intervention
Hepatitis A 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.
A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
In Brief
A Phase 2 clinical trial evaluating Hepatitis A Vaccine and Norovirus Bivalent VLP Vaccine for Healthy Volunteers and Norovirus, Prevention. Completed, enrolled 420 participants across 2 sites.
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), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers, Norovirus, Prevention
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionJun 2015
TodayJul 2026
First PostedJan 17, 2014
Enrollment StartMar 28, 2014
Primary CompletionJun 19, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.5 years ago
Interventions
Hepatitis A Vaccinebiological
Hepatitis A Vaccine IM injection
Norovirus Bivalent VLP Vaccinebiological
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection