At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
IC51 +2 morebiological
Likely dose
IC51 0.25 mlfrom 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.
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating IC51 for Encephalitis. Completed, enrolled 100 participants across 10 sites in 5 countries.
Detailed Summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis
CountriesAustralia, Denmark, Germany, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedJan 2010
Primary CompletionAug 2013
TodayJul 2026
First PostedJan 13, 2010
Enrollment StartJan 1, 2010
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.5 years ago
Interventions
IC51biological
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
IC51biological
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
IC51biological
0.5 ml, 2 i.m. vaccinations at Day 0 and 28