Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
Condition: Japanese Encephalitis; Japanese Encephalitis Virus Disease
MeSH terms: Virus Diseases; Encephalitis, Japanese; Encephalitis
Intervention: Live attenuated Japanese encephalitis chimeric virus vaccine; Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Japanese Encephalitis Virus Disease; IMOJEV™; CD.JEVAX™

Summary:

      The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus
      Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine
      [CD.JEVAX™]) after a single dose vaccination to support product registration.

      Primary Objective:

        -  To demonstrate the non-inferiority of the antibody response 28 days after administration
           of one dose of IMOJEV™ compared to the antibody response 28 days after administration of
           one dose of the CD.JEVAX™ control vaccine.

      Secondary Objectives:

        -  To describe the immune response to Japanese encephalitis (JE) in both vaccine groups
           using 50% plaque reduction neutralization assay (PRNT50) assays before and after a
           single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.

        -  To describe the safety of vaccination in all subjects up to 28 days and all serious
           adverse events up to 6-month after vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12 to 24 months on the day of inclusion

          -  In good general health, without significant medical history.

          -  Provision of informed consent form signed by at least one parent or other legally
             acceptable representative.

          -  Subject and parent/guardian 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 trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  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 IMOJEV™ components or history of a
             life-threatening reaction to a vaccine containing any of the same substances and
             vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other
             components (including Gelatin, kanamycin, and gentamicin).

          -  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.

          -  Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).

          -  Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4
             weeks following the trial vaccination.

          -  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 from the inclusion up to the 4 weeks following the
             trial vaccination.

          -  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 two consecutive weeks within
             the 4 weeks preceding 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.

          -  Thrombocytopenia or bleeding disorder contraindicated for vaccination with same
             administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.