Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Blood draw; IC51 has given in the parent study IC51-322
Intervention description: blood draw at Month 12, Month 24 and Month 36.; No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 9 Months
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a
      pediatric population vaccinated in the parent study IC51-322.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were
             enrolled as part of the immunogenicity subgroup of study IC51-322.

          -  Male or female healthy subjects aged ≥ 9 months to < 21 years at the time of enrolment
             into this study.

          -  Written informed consent by the subject, the subject's legal representative(s),
             according to local requirements, and written informed assent of the subject, if
             applicable.

        Exclusion Criteria:

          -  History of or clinical manifestation of any Flavivirus disease during study IC51-322.

          -  Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned
             during this study.

          -  Participation in another study with an investigational product during study IC51-322
             or IC51-324.

          -  History of or development of any immunodeficiency including post-organtransplantation
             after inclusion into study IC51-322.

          -  History of or development of an autoimmune disease during study IC51-322.

          -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune-modifying medications started during study IC51-322 up to first visit of study
             IC51-324. (For corticosteroids this means prednisone or equivalent at >= 0.05
             mg/kg/day. Topical or inhaled steroids are allowed).

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or
             hepatitis C virus (HCV).

          -  Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or
             alcohol addiction.

          -  Inability or unwillingness by the legal representative(s) and/or the subject (where
             applicable) to provide informed consent/assent and to abide by the requirements of the
             study.

          -  Persons who are committed to an institution (by virtue of an order issued either by
             the judicial or the administrative authorities).