At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 enrolled
Drug / intervention
Norovirus Bivalent 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.
Phase 1-2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety, Immunogenicity, and Efficacy Study in Healthy Adults of Intramuscular Norovirus Bivalent Virus-like Particle Vaccine in Experimental Human Norovirus GII.4 Disease
In Brief
A Phase 2 clinical trial evaluating Norovirus Bivalent Vaccine and Saline Comparator for Prevention From Norovirus Infection. Completed, enrolled 132 participants across 5 sites.
Detailed Summary
The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention From Norovirus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJul 2012
Primary CompletionMar 2014
Study CompletionMar 2014
TodayJul 2026
First PostedMay 31, 2012
Enrollment StartJul 16, 2012
Primary CompletionMar 1, 2014
Study CompletionMar 18, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.1 years ago
Interventions
Norovirus Bivalent Vaccinebiological
2 doses IM 28 days apart
Saline Comparatorbiological
2 doses IM 28 days apart