The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 192 subjects will be enrolled at 2 sites in Europe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
192
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
Time frame: Day 56
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
Time frame: Day 28
Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
Time frame: day 28 and 56
GMT and SCR for PRNT at Day 28 and HAV at Day 56
Time frame: day 28 and 56
Safety
Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)
Time frame: until 6 month after last vaccination
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