At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
NoV GI.1/GII.4 Bivalent VLP Vaccinebiological
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 II, Single Arm, Open Label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
In Brief
A Phase 2 clinical trial evaluating NoV GI.1/GII.4 Bivalent VLP Vaccine for Norovirus and Healthy Participants. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus, Healthy Participants
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
Primary CompletionApr 2015
First PostedJun 2015
Study CompletionSep 2015
TodayJul 2026
First PostedJun 18, 2015
Enrollment StartFeb 26, 2015
Primary CompletionApr 7, 2015
Study CompletionSep 9, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.0 years ago
Interventions
NoV GI.1/GII.4 Bivalent VLP Vaccinebiological
Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection