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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- prevalence of antibodies above the protective threshold for PT, FHA, diphtheria toxin, tetanus toxoid, PRP, and attenuated poliovirus types 1, 2 and 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 2month old over 至 6month old not（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
prevalence of antibodies above the protective threshold for PT, FHA, diphtheria toxin, tetanus toxoid, PRP, and attenuated poliovirus types 1, 2 and 3
时间窗: Visit 4
For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 4, prevalence of antibodies above the protective threshold required to give prevention against: - PT - FHA - diphtheria toxin - tetanus toxoid - PRP (includes the protective threshold required to give long-term prevention) - attenuated poliovirus types 1, 2 and 3
prevalence of antibodies above the protective threshold for HBsAg
时间窗: Visit 4 and Visit 8 for KD2-396(L) and KD2-396(H); Visit 6 for control
For KD2-396(L) and KD2-396(H) groups at Visit 4 and Visit 8, and the control vaccination group at Visit 6, prevalence of antibodies above the protective threshold required to give prevention against HBsAg
次要结局
- geometric mean antibody titers (GMT)(Visit 4 and Visit 8)
- prevalence of antibodies above the protective threshold(Visit 8)
- mean antibody titers (log2)(Visit 4 and Visit 8)
- GMT against HBsAg(Visit 4 and Visit 8 for KD2-396(L) and KD2-396(H) groups, Visit 6 for control vaccination group)