Status:
COMPLETED
Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Japanese Encephalitis
Hepatitis A
Eligibility:
All Genders
12-5 years
Phase:
PHASE2
Brief Summary
Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.
Detailed Description
This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 ye...
Eligibility Criteria
Inclusion
- Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
- Completion of vaccinations according to the national immunization schedule
- Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- 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.
- Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
Exclusion
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- 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 the trial vaccine or 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.
- Receipt of hepatitis A vaccine.
- History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
- Administration of any anti-viral within 2 months preceding the screening visit.
- History of central nervous system disorder or disease.
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- Planned participation in another clinical trial during the present trial period.
- 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, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
- Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
- Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
- History of seizures.
- Previous vaccination against flavivirus disease.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00621764
Start Date
March 1 2008
End Date
May 1 2013
Last Update
October 2 2014
Active Locations (3)
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1
Bangkok, Thailand, 10330
2
Bangkok, Thailand, 10400
3
Bangkok, Thailand, 10700