Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers
Condition: Japanese Encephalitis; Measles; Mumps; Rubella
MeSH terms: Measles; Rubella; Mumps; Encephalitis, Japanese; Encephalitis
Intervention: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus; Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus; Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
Intervention description: 0.5 mL each; Subcutaneous (SC); 0.5 mL each, Subcutaneous (SC); 0.5 mL each, subcutaneous (SC)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 542.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; 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.
    

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.