A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 680
- 主要终点
- The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
研究概览
简要总结
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
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 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Lifetime history of 0-4 sexual partners
排除标准
- •History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
研究组 & 干预措施
3
HPV VLP vaccine -Dose regimen 2
干预措施: Comparator: octavalent HPV Vaccine - dose formulation 2 (Biological)
4
HPV VLP vaccine -Dose regimen 3
干预措施: Comparator: octavalent HPV Vaccine - dose formulation 3 (Biological)
1
Gardasil
干预措施: Comparator: Gardasil (Biological)
2
HPV VLP vaccine -Dose regimen 1
干预措施: Comparator: octavalent HPV Vaccine - dose formulation 1 (Biological)
结局指标
主要结局
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
时间窗: 4 weeks post dose 3 injection
次要结局
未报告次要终点