At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Placebo +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 1, Randomized, Double-blind, Multi-center, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Healthy Japanese Infants 5 Months of Age at First Trial Vaccine Administration
In Brief
A Phase 1 clinical trial evaluating Placebo and HIL-214 for Gastroenteritis. Completed, enrolled 21 participants across 4 sites.
Detailed Summary
This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartAug 2023
First PostedAug 2023
Primary CompletionMay 2024
TodayJul 2026
First PostedAug 23, 2023
Enrollment StartAug 18, 2023
Primary CompletionMay 27, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.9 years ago
Interventions
Placebobiological
2 injections - given on Day 1 and the second given between Day 29 - Day 57
HIL-214biological
2 injections - given on Day 1 and the second given between Day 29 - Day 57