Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 9 Months
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®; Live attenuated vaccine

Summary:

      The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult
      and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity,
      reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data
      from other Asian pediatric populations.

      Primary objective:

      - To describe the safety profile of a single dose of IMOJEV®.

      Secondary objectives:

        -  To evaluate the immune response to JE 28 days after the administration of a single dose
           of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 months through 60 years on the day of inclusion.

          -  For adults: Informed consent form has been signed and dated by the subject. For
             minors: Informed consent form has been signed and dated by the parent or legally
             acceptable representative. In addition, in accordance with the Institution Ethics
             Committee / Institution Review Board requirements and as appropriate for the age of
             the subject, the subject may be required to sign and date the informed consent form if
             aged 12 to 17 years or assent form if aged 8 to 11 years.

          -  Subject and parent(s)/legally acceptable representative(s) are able to attend all
             scheduled visits and comply with all study procedures.

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
             least 1 year, or surgically sterile, or using an effective method of contraception or
             abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
             vaccination).

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the study
             vaccination) or planned participation during the present study period in another
             clinical study investigating a vaccine, drug, medical device, or a medical procedure.

          -  Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
             receipt of any vaccine in the 4 weeks following the study vaccination, except for
             inactivated influenza vaccination, which may be received at least 2 weeks before the
             study vaccine

          -  Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE),
             dengue, and yellow fever.

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months
             that might interfere with the assessment of the immune response.

          -  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 (for more than 2
             consecutive weeks within the 4 weeks preceding vaccination).

          -  History of flavivirus infection (confirmed either clinically, serologically, or
             virologically).

          -  History of central nervous system disorder or disease, including seizures.

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the study or to a vaccine containing
             any of the same substances.

          -  Known thrombocytopenia, contraindicating vaccination.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with study conduct or completion.

          -  Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection
             on 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.

          -  Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or
             planned receipt of any anti-viral in the 4 weeks following the study vaccination.
             Short-term antiviral drugs for flu or herpes can be administered provided there is a
             wash-out period of 1 week before the administration of the vaccine.

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.