jRCT2031200156已完成不适用
Phase 2 study of BK1304 in healthy children
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10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Response rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 6age old over 至 13age old not（—）
- 性别
- All
入选标准
- •A person who has written informed consent from legal guardian and has obtained an ascent from subject
排除标准
- •History of influenza virus infection or influenza vaccination within 180 days prior to the first dose of study drug
- •History of anaphylaxis to food or drug
- •Judged ineligible for the study by investigator
结局指标
主要结局
Response rate
Response rate of nasal IgA antibody
Geometric mean titer
Geometric mean titer of serum HI antibody
Geometric mean titer increase
Geometric mean titer increase of serum HI antibody
Seroconversion rate
Seroconversion rate of serum HI antibody
Seroprotection rate
Seroprotection rate of serum HI antibody
Adverse events
Adverse events
Adverse reactions
Adverse reactions
次要结局
未报告次要终点
研究者
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