Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

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.