A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 620
- 主要终点
- Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
研究概览
简要总结
The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.
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
- 16 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between 16- to 26-years-old
- •Has never had Pap testing or has only had normal Pap test results.
- •Lifetime history of 0 to 4 sexual partners
排除标准
- •History of an abnormal cervical biopsy result
- •History of a positive test for HPV; History of external genital/vaginal warts
- •Currently a user of illegal drugs or an alcohol abuser
- •History of severe allergic reaction that required medical attention
- •Are pregnant
- •Received a marketed HPV vaccine
- •Currently enrolled in a clinical trial
- •Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)
研究组 & 干预措施
1
V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
干预措施: V504 (Biological)
1
V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
干预措施: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological)
2
Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
干预措施: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological)
2
Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
干预措施: Comparator: Placebo (unspecified) (Biological)
结局指标
主要结局
Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
时间窗: 4 weeks post dose 3
次要结局
- Seroconversion percentages to HPV types contained in the administered vaccines(4 weeks post dose 3)