Drug Use Investigation for Cervarix®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,230
- 主要终点
- The number of subjects with solicited local adverse events
研究概览
简要总结
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject must be female
- •Subject must be aged 10 and over
排除标准
- •Subject with obvious fever
- •Subject with obvious severe acute disease
- •Subject with hypersensitivity to any component of Cervarix®
- •Other than above, subject who is in inappropriate conditions for vaccination
结局指标
主要结局
The number of subjects with solicited local adverse events
时间窗: 7 days after vaccination
Local adverse events: pain, redness, swelling at the vaccination site
The number of subjects with solicited general adverse events
时间窗: 7 days after vaccination
General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash
The number of subjects with unsolicited adverse events
时间窗: 30 days after vaccination
Any symptoms other than specified (local/systemic) symptoms
The number of subjects with serious adverse events
时间窗: 30 days after vaccination
次要结局
未报告次要终点