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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,675
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
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
Safety and Tolerability up to Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Time frame: Day 56
Rates of Serious Adverse Events and Medically Attended Adverse Events
Time frame: until Day 56
Changes in Laboratory Parameters
Time frame: until Day 56
SCR and GMT of Subjects With Concomitant Vaccinations
Time frame: until Day 56
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