NCT00378560已完成2 期
V501 Phase II Efficacy Study in Women Aged 18 to 26
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,021
- 主要终点
- Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
研究概览
简要总结
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Subject Aged 18 To 26 Years
- •With 1-4 Lifetime Sexual Partners
排除标准
- •Male Subject
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Comparator: Placebo (Biological)
2
Experimental
Vaccine
干预措施: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological)
结局指标
主要结局
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
时间窗: Over 30 months
Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
次要结局
- Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)(At one month after completed vaccination series (Month 7))
- Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)(At one month after completed vaccination series (Month 7))
- Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)(At one month after completed vaccination series (Month 7))
- Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)(At one month after completed vaccination series (Month 7))
研究者
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