JPRN-jRCT2080223917已完成3 期
KD-370 Phase III Clinical Study
KM Biologics Co.,Ltd.0 个研究点目标入组 496 人开始时间: 2018年5月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 496
研究概览
简要总结
Subcutaneously, three doses of KD-370 were administered to infants ranging from 2 months or older to under 60 months as primary immunization, and the immunogenicity of the KD-370 was confirmed to bear comparison with that of simultaneous administration of ActHIB (R) and Quattrovac (R). Moreover, subcutaneous administration of a total of four doses including a booster immunization resulted in higher antibody titers. Also, in terms of the safety of the KD-370, it is considered to have clinically acceptable safety as well as simultaneous administration of ActHIB (R) and Quattrovac (R).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2month old 至 <= 59month old（—）
- 性别
- All
入选标准
- •Infants who are able to receive 4 doses of the investigational drug at defined intervals between the age of 2 months and 60 months
- •- Infants who obtain written informed consent from their legally acceptable representatives
排除标准
- •- Infants having a medical history of Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (based on interview of their legally acceptable representatives)
- •- Infants who have received vaccination for Hib, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (Confirm Mother and Child Health Handbook)
- •- Infants who previously exhibited anaphylaxis by components contained in the investigational drug
- •- Infants who have received another investigational drug in another clinical trial within 4 months (120 days) prior to administration of investigational drug in this trial or those who plan to participate in another clinical trial during this clinical trial
- •- Infants who are judged as ineligible for participation in this study by the principal investigator or sub-investigator
研究者
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