Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Inclusion Criteria:

- Male or female healthy children and adolescents aged >=2 months to <18 years at the
time of first vaccination

- Written informed consent by the subject's legal representative(s), according to local
requirements, and written informed assent of the subject, if applicable

- Female subjects: either no childbearing potential or negative pregnancy test. For
females after menarche willingness to practice a reliable method of contraception.

- The subject is planning to travel to an area where JE is endemic after completion of
the vaccination schedule. Exposure to JE should be avoided until 1 week after the
second IC51 dose and subjects should return from travel to JE endemic areas before
the Month 7 visit. The planned travel to JE endemic areas should not interfere with
the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria:

- Clinical manifestation or history of any Flavivirus disease

- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus
and Dengue at any time prior or during the study

- History of immunodeficiency or immunosuppressive therapy

- Known HIV, HBV or HCV infection

- History of hypersensitivity reactions to other vaccines

- Acute febrile infection at each visit during which the subject receives a vaccination

- Active or passive immunization within 1 week before and 1 week after each IC51
vaccination.