JPRN-jRCT2080224800已完成3 期
A observer-blind, active-controlled, multi-center, phase III, comparative study of the efficacy and safety of BK1601 and MR vaccine in Japanese pediatric subjects aged from 12 months to 24 months old.
The Research Foundation for Microbial Diseases of Osaka University0 个研究点目标入组 374 人开始时间: 2019年7月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12month old 至 <= 24month old（—）
- 性别
- All
入选标准
- •Japanese healthy and pediatric subjects aged from 12 months to 24 months old at time of on administration.
- •-Subjects who had not been vaccinated against measles and rubella.
- •-Subject's guardians (Parents) are able and willing to comply with study procedures and provide the signed informed consent.
排除标准
- •-Subjects who had history of measles or rubella.
- •-Subjects who had are known exposure to measles or rubella during the period starting from 28 days or less prior to study administration.
- •-Subjects who had history of anaphylaxis to food or drug.
- •-Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease.
- •-Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy.
- •-Subjects who received blood transfusion and/or gamma globulin preparation from 3 months (Day-84) or less, and/or received high-dose therapy (200 mg /kg or more) of gamma globulin preparation from 6 months (Day-168) or less prior to study administration.
- •-Subjects who have received other investigational products from 4 month (Day-112) or less prior to study administration.
- •-Subjects who received a live vaccine from 27 days (Day-27) or less prior, and/or inactivated vaccine from 6 days (Day-6) or less prior and/or toxoid from 6 days (Day-6) or less prior to study administration.
- •-Those who are medically decided to be unsuitable for this study by the investigator or the sub investigator due to factors other than above.
研究者
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Phase III study of BK1601 in Japanese pediatric subjectsPrevention of measles and rubellaJPRN-jRCT2080225149The Research Foundation for Microbial Diseases of Osaka University120
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