Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Jul 15, 2011

Keywords

ClinConnect Summary

All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Gender

ALL

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.