At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
IXIARO +1 morebiological
Likely dose
IXIARO 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.
Long-Term Immunity and Safety With or Without a Booster Dose Following Primary Vaccination With the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population in a JEV-Endemic Country. Open-Label, Randomized, Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating IXIARO for Japanese Encephalitis. Completed, enrolled 300 participants across 3 sites.
Detailed Summary
This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis
CountriesPhilippines
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedFeb 2011
Primary CompletionNov 2011
Study CompletionOct 2013
TodayJul 2026
First PostedFeb 15, 2011
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2011
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.4 years ago
Interventions
IXIARObiological
0.25 ml i.m. (milliliter, intramuscular)
IXIARObiological
0.5 ml i.m. (milliliter, intramuscular)