JPRN-jRCT2080223918已完成2 期
KD-370 Phase II Study on route of administration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
研究概览
简要总结
As a result of evaluating immunogenicity and safety of intramuscular injection of KD-370 for infants ranging from 2 months or older to under 60 months in comparison to the subcutaneous injection, the immunogenicity was similar in intramuscular and subcutaneous injection. In terms of safety, intramuscular injection was expected to reduce the injection site reaction compared to subcutaneous injection, and it was confirmed to be acceptable safety for children.
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 with fibrodysplasia ossificans progressiva
- •- Infants who are judged as ineligible for participation in this clinical trial by the principal investigator or sub-investigator
研究者
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