Status:
COMPLETED
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Japanese Encephalitis
Hepatitis A
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief 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 v...
Detailed Description
This is a Phase III trial in toddlers in Thailand and the Philippines.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00735644
Start Date
August 1 2008
End Date
August 1 2009
Last Update
April 21 2015
Active Locations (8)
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1
Alabang, Philippines
2
Bayanan, Philippines
3
Buli, Philippines
4
Cupang, Philippines