A multicenter, open-label, uncontrolled study to confirm the safety and immunogenicity of single intramuscular dose of KD2-396 in infants who have completed three doses of DPT-IPV, freeze-dried Haemophilus b vaccine (hereafter Hib vaccine) and hepatitis B vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Geometric mean fold rise (GMFR)
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 2month old over 至 17month old not（—）
- 性别
- All
入选标准
- •Subjects who received three doses of vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Haemophilus influenzae type b infection (Hib infection) and hepatitis B (as documented in the Maternal and Child Health Handbook)
- •Subjects who can receive the investigational product by 17 months of age
- •Subjects who obtain written informed consent from their legally acceptable representatives
排除标准
- •Subjects with a medical history of pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Hib infection, or hepatitis B (based on the interview of their legally acceptable representatives)
- •Subjects who have completed four doses of vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio) and Hib infection (as documented in the Maternal and Child Health Handbook)
- •Subjects who received hepatitis B vaccine and HBIG to prevent vertical transmission
- •Subjects who have exhibited anaphylaxis previously due to ingredients of the investigational product
- •Patients with fibrodysplasia ossificans progressive
- •Subjects who participated in another study and received other investigational products within past 4 months (120 days) from the date of the investigational product vaccination
- •Subjects with an interval of less than 6 months between the third vaccination of DPT-IPV and Hib vaccine and the investigational product vaccination
- •Subjects with an interval of less than 1 month between the third vaccination of hepatitis B vaccine and the investigational product vaccination
- •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
Geometric mean fold rise (GMFR)
for PT, FHA, diphtheria toxin, tetanus toxoid, PRP, and HBsAg before and after the investigational product vaccination
Mean difference in antibody titers (log2)
against attenuated poliovirus types 1, 2, 3 before and after the investigational product vaccination
Incidence and causal relationship of adverse events
时间窗: up to 27 days after the investigational product vaccination
all adverse events, adverse events resulting in death, serious adverse events other than death, important adverse events, and severe (Grade 3 or higher) adverse events occurring up to 27 days after the investigational product vaccination
Incidence, severity, number of days to onset, duration, and causal relationship of solicited local adverse events
solicited local adverse events
Incidence, severity, number of days to onset, duration, and causal relationship of solicited systemic adverse events
solicited systemic adverse events
Incidence, severity, number of days to onset, duration, and causal relationship of unsolicited adverse events
unsolicited adverse events
Maximum body temperature
时间窗: from vaccination to 6 days after the investigational product vaccination
from vaccination of the investigational product to 6 days after the investigational product vaccination
次要结局
- Prevalence of antibodies above the protective threshold(after the investigational product vaccination)
- Geometric mean antibody titers (GMT)(after the investigational product vaccination)
- Mean antibody titers (log2)(after the investigational product vaccination)