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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Seroprotection rate of measles virus neutralizing antibodies
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
- 12month old over 至 24month old under（—）
- 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.
结局指标
主要结局
Seroprotection rate of measles virus neutralizing antibodies
Seroprotection rate of measles virus neutralizing antibodies after study administration
Seroprotection rate of rubella virus HI antibodies
Seroprotection rate of rubella virus HI antibodies after study administration
次要结局
未报告次要终点
研究者
研究点 (1)
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