NCT00290277已完成3 期
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
研究概览
简要总结
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
详细描述
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
- •Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
- •Subjects must have a negative urine pregnancy test.
- •Healthy subject before entering the study as established by medical history and clinical examination.
- •Subject must be of non-childbearing potential.
排除标准
- •Pregnant or breastfeeding.
- •Previous vaccination against HPV.
- •Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
- •History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."
结局指标
主要结局
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
次要结局
- To evaluate safety and reactogenicity throughout the study period.
研究者
研究点 (9)
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