Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Condition: Japanese Encephalitis; Hepatitis A
MeSH terms: Hepatitis A; Encephalitis, Japanese; Hepatitis; Encephalitis
Intervention: Japanese encephalitis vaccine; Japanese encephalitis vaccine; Japanese encephalitis vaccine; Japanese encephalitis vaccine (Acambis); Hepatitis A vaccine
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1200.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

Summary:

      This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in
      toddlers aged 12-18 months.

      Primary objective:

      To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi
      pasteur.

      Secondary objective:

      To describe the safety of vaccination in all subjects
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 12 to 18 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, and by at least one independent witness if required by
             local regulations.

          -  Subject and parent/legally acceptable representative able to attend all scheduled
             visits and comply with all trial procedures.

          -  Completion of vaccinations according to the national immunization schedule.

        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.