Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IMOJEV
Intervention description: 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 2 Years
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®

Summary:

      The aim of this study was to document the immunogenicity and safety of a booster dose of
      IMOJEV administered at least 12 months after the primary dose.

      Primary objective:

        -  To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a
           booster dose of IMOJEV administered at least 12 months after primary vaccination with
           IMOJEV.

      Exploratory objectives:

        -  To describe the safety profile of a booster dose of IMOJEV® .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months
             before booster vaccination

          -  Age 2 to 4 years on the day of inclusion

          -  In good general health at the time of inclusion

          -  Informed Concent Form signed and dated by parent(s) or another legally acceptable
             representative(s)

          -  Subject and parent(s)/legally acceptable representative(s) able to attend all
             scheduled visits and comply with all study procedures.

        Exclusion Criteria:

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the trial
             vaccination) or planned participation during the present trial period in another
             clinical study investigating a vaccine, drug, medical device, or a medical procedure
             in the 4 weeks preceding the study vaccination

          -  Known or suspected congenital or acquired immunodeficiency, or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months, or long-term systemic corticosteroids therapy

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months,
             that might interfere with the assessment of the immune response

          -  Previous vaccination against flavivirus disease, including JE, with another vaccine,
             except with IMOJEV® while participating in JEC12

          -  Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4
             weeks following the study vaccination

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned
             receipt of any vaccine in the 4 weeks following the trial vaccination, except for
             inactivated influenza vaccination, which may be received at least 2 weeks before the
             study vaccine

          -  History of central nervous system disorder or disease, including seizures

          -  Planned receipt of any JE vaccine during the course of the study

          -  History of flavivirus infection (confirmed either clinically, serologically or
             virologically)

          -  Administration of systemic corticosteroids for more than 2 consecutive weeks within
             the 4 weeks preceding vaccination

          -  Thrombocytopenia, contraindicating vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating vaccination

          -  Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3
             days before vaccination as well as the day of vaccination, according to Investigator
             judgment. A prospective subject should not be included in the study until the
             condition has resolved or the febrile event has subsided

          -  In an emergency setting or hospitalized involuntarily

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study.