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|NCT02532569 : Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj|
|Ages||Min: 6 Years Max: 6 Years|
- Parent/guardian (legally authorized representative) has given voluntary written
consent to the subject's participation after being fully informed of the purpose,
methods, risks, and benefits of the study.
- Male and female children who have completed the primary 3 doses of JEV in the
- Male and female children reaching at least 6 years of age on the day of booster
dosing of JEV.
- Male and female children who are identified to be healthy based on physical
examina-tion and medical history.
- Children who have acute febrile illness with tympanic temperature of ?38.0 ? on the
day of booster dosing of JEV.
- Children who have moderate or severe acute disease (regardless of fever).
- Children who have history of encephalitis, encephalopathy, cerebromeningitis, or
- Children who have received JEV (including live JEV) other than the investigational
products administered in the KD287-BR-CT-301study.
- Children who have had fever (? 40 °C) or systemic allergy within 48 hours after
- Children who have shown anaphylactic reaction to the investigational products
administered in the KD287-BR-CT-301study or who are likely to be allergic to the
ingredients of the investigational product.
- Children who have been diagnosed with immunodeficiency such as acquired immune
de?ciency or who have family history of immunodeficiency.
- Children who have received other vaccines within 28 days before booster dosing of JEV
(vaccines to be administered according to the national vaccination program such as
5th dose of DTaP, 4th dose of IPV, and 2nd dose of MMR should be given 14 days apart
from the day of booster dosing of JEV).
- Children who have received immunosuppressive dose of systemic corticosteroids
thera-py within 28 days before booster dosing of JEV (Systemic corticosteroids
administered at doses corresponding to ?0.5 mg/kg/day of prednisolone for maximum of
14 consecutive days is exceptionally allowed).
- There is a possibility that immune globulin preparations has not been excreted enough
on the day of booster dosing of JEV if children have received such a product.
- Children who are currently participating or planning to participate in other clinical
stud-ies during the study period.
- Other ineligible conditions judged at the discretion of principal investigators or
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