A multicenter, rater-blinded, randomized, active-controlled, parallel-assignment study to confirm the safety and immunogenicity of vaccination of KD2-396(L) and KD2-396(H) and to examine the optimal dose of hepatitis b virus surface antigen (hereafter HBsAg) in infants aged >=2 months to < 6 months at the time of the first vaccination

Yasuhiko Shinmura0 个研究点目标入组 150 人开始时间: 2023年10月12日最近更新: 2024年5月27日

研究概览

暂无简介。

•(1)Infants aged >=2 months to < 6 months at the time of the first vaccination.
•(2)Subjects who obtain written informed consent from their legally acceptable representatives.

•(1)Subjects with a medical history of pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Haemophilus influenzae type b (hereafter Hib) infection, or hepatitis B.
•(2)Subjects who received vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Hib infection or hepatitis B.
•(3)Subjects who received HBIG to prevent vertical transmission.
•(4)Subjects who have exhibited anaphylaxis previously due to ingredients of the investigational product.
•(5)Patients with fibrodysplasia ossificans progressive.
•(6)Subjects who have participated in another study and received other investigational products within the past 4 months (120 days) from the date of the investigational product vaccination, or who are scheduled to participate in another study during the participation period in this study.
•(7)Subjects who are judged ineligible for participation in this study by the principal investigator or the subinvestigator.

发起方

Yasuhiko Shinmura