Status:
COMPLETED
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Japanese Encephalitis
Measles
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits...
Detailed Description
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Aged 12 to 18 months on the day of inclusion .
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- Subject in good health based on medical history and physical examination.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
- Subject and parent/legally acceptable representative or delegate 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 first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- 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 up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
- Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
- Receipt of blood in the past 6 months that might interfere with the assessment of the immune response
- Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months
- Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months
- 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 history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity.
- History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically.
- 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 .
- Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin.
- Known history of thrombocytopenia.
- Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination.
- History of central nervous system disorder or disease, including seizures and febrile seizures.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT01188343
Start Date
August 1 2010
End Date
December 1 2012
Last Update
August 15 2014
Active Locations (3)
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1
Taichung, Taiwan
2
Taipei, Taiwan
3
Taoyuan District, Taiwan