JPRN-jRCT2080225149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 5 years to 7 years old.
The Research Foundation for Microbial Diseases of Osaka University0 个研究点目标入组 120 人开始时间: 2020年4月1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
- 120
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
- >= 5age old 至 <= 7age old（—）
- 性别
- All
入选标准
- •1. Japanese healthy and pediatric subjects aged from 5 years to 7 years old before elementary school.
- •2. Subjects who had been vaccinated against measles and rubella at the age of one.
- •3. Subjects who had not been vaccinated against measles and rubella since the age of one.
- •4. Subject's guardians (Parents) are able and willing to comply with study procedures and provide the signed informed consent.
排除标准
- •1. Subjects who had history of measles or rubella.
- •2. Subjects who had are known exposure to measles or rubella during the period starting from 28 days or less prior to study administration.
- •3. Subjects who had history of anaphylaxis to food or drug.
- •4. Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease.
- •5. Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy.
- •6. 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.
- •7. Subjects who have received other investigational products from 4 month (Day-112) or less prior to study administration.
- •8. 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.
- •9. 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
相似试验
已完成
3 期
Phase III study of BK1601 in Japanese pediatric subjectsPrevention of measles and rubellaJPRN-jRCT2080224800The Research Foundation for Microbial Diseases of Osaka University374
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