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|NCT02492165 : Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects|
|Ages||Min: 9 Months Max: 60 Years|
- Aged 9 months through 60 years on the day of inclusion.
- For adults: Informed consent form has been signed and dated by the subject. For
minors: Informed consent form has been signed and dated by the parent or legally
acceptable representative. In addition, in accordance with the IEC/IRB requirements
and as appropriate for the age of the subject, the subject may be required to sign
and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to
- Subject and parent(s)/legally acceptable representative(s) are able to attend all
scheduled visits and comply with all study procedures.
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
least 1 year, or surgically sterile, or using an effective method of contraception or
abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
- Participation at the time of study enrollment (or in the 4 weeks preceding the study
vaccination) or planned participation during the present study period in another
clinical study investigating a vaccine, drug, medical device, or a medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
receipt of any vaccine in the 4 weeks following the study vaccination, except for
inactivated influenza vaccination, which may be received at least 2 weeks before the
- Previous vaccination against flavivirus disease, including JE, dengue, and yellow
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
that might interfere with the assessment of the immune response.
- 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 (for
more than 2 consecutive weeks within the 4 weeks preceding vaccination).
- History of flavivirus infection (confirmed either clinically, serologically, or
- History of central nervous system disorder or disease, including seizures.
- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the study or to a vaccine containing
any of the same substances.
- Known thrombocytopenia, contraindicating vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- Chronic illness that, in the opinion of the investigator, is at a stage where it
might interfere with study conduct or completion.
- Febrile illness (temperature ? 38.0°C) or moderate or severe acute illness/infection
on the day of vaccination, according to Investigator judgment. A prospective subject
should not be included in the study until the condition has resolved or the febrile
event has subsided.
- Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or
planned receipt of any anti-viral in the 4 weeks following the study vaccination.
Short-term antiviral drugs for flu or herpes can be administered provided there is a
wash-out period of 1 week before the administration of the vaccine.
- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed study.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02492165
| Link to official Clinicaltrials.gov listing