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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Geometric mean titer (GMT) and GMT increase
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, active control, randomized, parallel group comparison, observer-blind
- 主要目的
- Prevention Purpose
入排标准
- 年龄范围
- 5age old over 至 7age old under（—）
- 性别
- All
入选标准
- •Japanese healthy and pediatric subjects aged from 5 years to 7 years old before elementary school.
- •Subjects who had been vaccinated against measles and rubella at the age of one.
- •Subjects who had not been vaccinated against measles and rubella since the age of one.
- •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.
结局指标
主要结局
Geometric mean titer (GMT) and GMT increase
Geometric mean titer (GMT) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.
Seroprotection rate
Seroprotection rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.
Adverse events and adverse reactions
Adverse events and adverse reactions
次要结局
- Geometric mean titer (GMT) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration
- Seroconversion rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration
- Geometric mean titer (GMT) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies compared by MR vaccine had been vaccinatedat at the age of one
- Seroconversion rate of measles virus neutralizing antibodies and rubella virus HI antibodies compared by MR vaccine had been vaccinatedat at the age of one
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Phase 2 study of BK1304 in healthy childrenjRCT2031200156The Research Foundation for Microbial Diseases of Osaka University120
已完成
2 期
Phase 2 study of BK1304 in healthy childrePrevention of influenzaJPRN-jRCT2031200156Fuji Hideyuki120
未知
2 期
Clinical trial of KIB-PCI in healthy Japanese childreProphylaxis of new type of influenza infectionJPRN-jRCT2080222503DAIICHISANKYO Co.,Ltd.150
已完成
不适用
Phase 3 study2 of KCI002 in pediatric patientsConstipationjRCT2031220631Magmitt Pharmaceutical Co., Ltd.50
已完成
1 期
A phase I clinical study of KSP-0243Healthy ConditionJPRN-jRCT2071200087Shimizu Yoshitaka144