A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Sanofi Pasteur SA0 sites300 target enrollmentNovember 17, 2015

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur SA

•1\. Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
•2\. Completion of vaccinations according to the national immunization schedule
•3\. Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
•4\. Previous receipt of two doses of a mouse\-brain\-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
•5\. Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 300
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•1\. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
•2\. 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.
•3\. Known systemic hypersensitivity to any of the vaccine components or history of a life\-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
•4\. Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
•5\. Receipt of blood or blood\-derived products in the past 3 months, that might interfere with the assessment of the immune response.
•6\. Receipt of hepatitis A vaccine.
•7\. History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
•8\. Administration of any anti\-viral within 2 months preceding the screening visit.
•9\. History of central nervous system disorder or disease.
•10\. Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.