Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Exclusion Criteria

• •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
• •Planned participation in another clinical trial during the present trial period.
• •Known or suspected congenital or acquired immunodeficiency, 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 a vaccine containing any of the same substances.
• •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
• •Administration of any anti-viral within 2 months preceding V01.
• •History of central nervous system disorder or disease, including seizures.
• •Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
• •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• •Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
• •Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
• •Receipt of any JE vaccine or hepatitis A vaccine.
• •Previous vaccination against flavivirus disease.
• •History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
• •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
• •Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.