study of japanese encephalitis chimeric virus vaccine given with measles-mumps-rubella vaccine in taiwanese toddlers

Conditions: Japanese Encephalitis; Measles; Mumps; Rubella

Summary: this study is designed to compare the immunogenicity of japanese encephalitis chimeric virus vaccine (je-cv) and measles-mumps-rubella (mmr)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months. primary objective: * to demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of je-cv and mmr compared to the antibody responses after the single administration of je-cv and mmr vaccine. secondary objectives: * to describe the immune response to je cv and mmr before and after one dose of je cv and mmr vaccine, respectively. * to describe the safety of a single dose of je-cv and mmr vaccine (given separately at a 6-week interval and the safety of the concomitant administration of je-cv and mmr vaccine in all subjects up to 6 months after last vaccination.

all participants will receive japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.

Eligibility criteria:
inclusion criteria * aged 12 to 18 months on the day of inclusion . * born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg. * subject in good health based on medical history and physical examination. * provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read. * subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures. exclusion criteria * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines. * planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. in the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial. * previous vaccination against measles, measles-mumps-rubella (mmr), or flavivirus disease, including japanese encephalitis (je). * receipt of blood in the past 6 months that might interfere with the assessment of the immune response * receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months * receipt of intramuscular treatment of immunoglobulin or hepatitis b immunoglobulin in the past 3 months * 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 history of human immunodeficiency virus, hepatitis b surface antigen, or hepatitis c seropositivity. * history of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically. * 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 . * known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin. * known history of thrombocytopenia. * administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination. * history of central nervous system disorder or disease, including seizures and febrile seizures. * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.

Keywords: japanese encephalitis japanese encephalitis chimeric virus vaccine measles mumps rubella