Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IXIARO; IXIARO
Intervention description: 0.25 ml i.m. (milliliter, intramuscular); 0.5 ml i.m. (milliliter, intramuscular)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 9 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immune response; IC51-325; Japanese Encephalitis; Intercell AG

Summary:

      This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years
      and 7 months who have been vaccinated with IXIARO in study IC51-323.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children and adolescents who have completed study IC51-323 and received both IXIARO
             vaccinations according to protocol.

          -  Children who have received the dose confirmed for their age group.

          -  Male or female healthy children and adolescents aged ≥9 months to <17 years and 7
             months at the time of enrolment into this study.

          -  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
             (pregnancy test to be performed in female subjects after onset of menarche) at Visits
             1, 2 and 2a as stipulated by the protocol. For females after menarche willingness to
             practice a reliable method of contraception

        Exclusion Criteria:

          -  Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow
             fever, West Nile virus and Dengue fever at any time prior to or planned during the
             study.

          -  History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51
             325.

          -  Participation in another study with an investigational drug during IC51 323 or IC51
             325.

          -  Planned active or passive immunization within 2 weeks before and 1 week after the
             IXIARO booster.

          -  History of or development of any immunodeficiency including post-organ-transplantation
             after inclusion into IC51-323 or IC51 325.

          -  History of or development of an autoimmune disease during study IC51-323 or IC51 325.

               -  Administration of chronic (defined as more than 14 days) immunosuppressants or
                  other immune-modifying medications started during IC51-323 or IC51 325. (For
                  corticosteroids, this would mean prednisone or equivalent at >0.05 mg/kg/day;
                  topical and inhaled steroids are allowed).

          -  Acute febrile infection at Visit 2 (only for the Booster Group).

          -  Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable
             contraception in female subjects after onset of menarche.

          -  Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring
             withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring
             emergency treatment or hospital admission during IC51-323 or IC51 325.

          -  History of urticaria after hymenoptera envenomation, drugs, physical or other
             provocations or of idiopathic cause during IC51-323 or IC51 325.

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV)
             (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus
             (HCV).

          -  Illicit drug use 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 have been committed to an institution (by a court or by an authority).