EUCTR2014-004581-16-Outside-EU/EEA进行中（未招募）不适用
An Immunogenicity and Safety Study of GARDASIL™ in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
Merck Sharp & Dohme (China) Ltd.0 个研究点目标入组 600 人开始时间: 2015年4月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Healthy Chinese female subjects aged 9-45 years old and male aged 9-15 years old upon receipt of the first study vaccination; not pregnant now for post-pubertal female subjects.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 230
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 370
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key subjects must have temperature <37.1 degrees C within 24 hours prior to the first injection; without a history of severe allergic reaction or allergic reaction to any vaccine component; no history of immune globulin or blood-derived products within 6 months prior to first injection or plan to receive any through the completion of the study; negative history of splenectomy, immune disorder or receiving immunosuppressives; no history of immunocompromised or HIV infection; no history of thrombocytopenia or any coagulation disorder; no history of abnormal Pap test or biopsy showing CIN or worse; = 4 lifetime sexual partners.
研究者
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