The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged \> or = 18 years
This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years. Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
374
SCR (Seroconversion Rate) at Day 56
Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer
Time frame: day 56
SCR at Day 10, 28 and 35
Time frame: Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56
Time frame: Day 10, 28, 35 and 56
Safety
AEs, Local and systemic tolerability, Safety laboratory parameters
Time frame: Study duration
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