A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,030
- 主要终点
- Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
研究概览
简要总结
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese females
- •Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
- •Lifetime history of 0 to 4 male or female sexual partners
- •No oral temperature ≥37.5 centigrade within 24 hours prior to injection
排除标准
- •Received a marketed HPV vaccine
- •Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
- •Known history of positive test for HPV
- •Known history of genital warts
- •Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
- •History of splenectomy, known immune disorders, or receiving immunosuppressives
- •Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
研究组 & 干预措施
V501
Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
干预措施: V501 (Biological)
结局指标
主要结局
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
时间窗: Up to Month 48
The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.
次要结局
未报告次要终点