At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,869 enrolled
Drug / intervention
IC51 Japanese Encephalitis +2 morebiological
Likely dose
IC51 Japanese Encephalitis 6 mcgfrom 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.
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating IC51 Japanese Encephalitis, Havrix®720, and 1 other intervention for Encephalitis. Completed, enrolled 1,869 participants across 2 sites.
Detailed Summary
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis
CountriesPhilippines
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2009
Enrollment StartMar 2010
Primary CompletionFeb 2011
Study CompletionJul 2011
TodayJul 2026
First PostedDec 31, 2009
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago
Interventions
IC51 Japanese Encephalitisbiological
6 mcg or 3 mcg im. at day 0 and day 28
Havrix®720biological
0.5 ml im. at day 0 and month 7
Prevnarbiological
0.5 ml im. at day 0 and day 56 and month 7