Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Japanese Encephalitis, Hepatitis A
About this trial
This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Sham Comparator
JE-CV GPO MBP (Lot 1)
JE-CV GPO MBP (Lot 2)
JE-CV GPO MBP (Lot 3)
JE-CV WRAIR (Group 4)
Hepatitis A (Group 5)
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine