KD6-287 Phase III Study

KM Biologics Co., Ltd.0 个研究点目标入组 150 人开始时间: 2024年10月16日最近更新: 2025年3月13日

试验速览

暂无简介。

•(1) Healthy infants and children who can receive investigational products three times from 6 to <90 months of age
•(2) Written informed consent by a legally acceptable representative

•(1) Has a history of Japanese encephalitis
•(2) Has a history of immunization against Japanese encephalitis
•(3) Has a known history of anaphylaxis caused by ingredients of the investigational products
•(4) Presence of fibrodysplasia ossificans progressiva
•(5) Has participated in a clinical study and received other investigational products within 4 months (120 days) before the first dose or plans to participate in other clinical study during this study
•(6) Has received blood transfusion or gamma globulin preparation within 3 months (90 days) before the first dose or massive-dose gamma globulin therapy (>= 200 mg/kg) within 6 months (180 days) before the first dose
•(7) Has received treatment that may affect the immune function* within 6 months (180 days) before the first dose
•Radiotherapy, immunosuppressive drugs (external use is allowed), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone, corticosteroids (>= 2 mg/kg/day of prednisolone equivalent for 14 days or longer, external use is allowed)
•(8) Is ineligible for other reasons in the investigator (sub-investigator)'s opinion

Seroconversion rate of neutralizing antibodies after the third dose

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发起方