Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice
研究概览
简要总结
This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening
排除标准
- •Unable to provide written informed consent
- •Any woman who is known being pregnant at screening
- •Subject who is participating or going to participate in another study which involves GARDASIL administration
结局指标
主要结局
Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice
时间窗: 24 months
Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Number of participants with adverse events following any dose of vaccine
时间窗: within 30 days after each dose
Number of participants with adverse events following any dose of vaccine
次要结局
未报告次要终点