JPRN-jRCT2031220411已完成1 期
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
Shinmura Yasuhiko0 个研究点目标入组 30 人开始时间: 2022年10月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Infants under 17 months of age who have completed three doses of commercially available DPT-IPV, Hib vaccine and HB vaccine were vaccinated a single intramuscular dose of KD2-396 as an additional vaccination. As a result, serious concerns about safety profile for KD2-396 was not observed and KD2-396 was considered as tolerable in clinical. KD2-396 was also shown to be capable of inducing antibodies against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, 3, PRP and HBsAg.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2month old 至 < 17month old（—）
- 性别
- All
入选标准
- •1)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)
- •2)Subjects who can receive the investigational product by 17 months of age
- •3)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), Hib infection, or hepatitis B (based on the interview of their legally acceptable representatives)
- •2)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)
- •3)Subjects who received hepatitis B vaccine and 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 participated in another study and received other investigational products within past 4 months (120 days) from the date of the investigational product vaccination
- •7)Subjects with an interval of less than 6 months between the third vaccination of DPT-IPV and Hib vaccine and the investigational product vaccination
- •8)Subjects with an interval of less than 1 month between the third vaccination of hepatitis B vaccine and the investigational product vaccination
- •9)Subjects who are judged ineligible for participation in this study by the principal investigator or the subinvestigator
研究者
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