At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,675 enrolled
Drug / intervention
Japanese Encephalitis purified inactivated vaccine (IC51) +1 morebiological
Likely dose
Japanese Encephalitis purified inactivated vaccine (IC51) 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 Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating Japanese Encephalitis purified inactivated vaccine (IC51) and Placebo for Japanese Encephalitis. Completed, enrolled 2,675 participants.
Detailed Summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
Study CompletionNov 2006
First PostedJan 2008
TodayJul 2026
First PostedJan 30, 2008
Enrollment StartOct 1, 2005
Study CompletionNov 1, 2006
TodayJul 2, 2026
Posted 18.4 years ago
Interventions
Japanese Encephalitis purified inactivated vaccine (IC51)biological
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Placebobiological
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28