A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,055
- 主要终点
- Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
研究概览
简要总结
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
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
- 10 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents and pre-adolescents with no prior sexual history
- •Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners
排除标准
- •Prior Human Papillomavirus (HPV) vaccination
- •Prior abnormal Paps
- •Prior history of genital warts
研究组 & 干预措施
2
60% Formulation qHPV Vaccine
干预措施: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological)
1
100% Formulation qHPV Vaccine
干预措施: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological)
3
40% Formulation qHPV Vaccine
干预措施: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological)
4
20% Formulation qHPV Vaccine
干预措施: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological)
结局指标
主要结局
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
时间窗: Week 4 Postdose 3 (Month 7)
次要结局
未报告次要终点