long-term immunogenicity and safety of fourth administration of boryung cell-culture japanese encephalitis vaccineinj

Conditions: Japanese Encephalitis

Summary: a multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of boryung cell-culture japanese encephalitis vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in korean children aged 6 years who received primary 3 doses with encevac® or japanese encephalitis vaccine-gcc® inj.

this is a follow-up study of kd287-br-ct-301 (clinicaltrials.gov identifier: nct01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture japanese encephalitis vaccine (encevac®) compared with that of a mouse brain-derived japanese encephalitis vaccine (japanese encephalitis vaccine-gcc® inj). subjects participated in kd287-br-ct-301 study were to receive 3 doses of japanese encephalitis vaccine (jev) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of jev are the target population in this study. the purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of jev, which will be given as boryung cell-culture japanese encephalitis vaccine inj, proven to be same with encevac® but manufactured by a different manufacturer.

Eligibility criteria:
inclusion criteria: * 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 kd287-br-ct-301study. * 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 examination and medical history. exclusion criteria: * 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 convulsion. * 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 vaccination. * 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 deficiency 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. * children who have received immunosuppressive thera-py within 28 days before booster dosing of jev. * 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 subinvestigators.