A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,158
- 主要终点
- Number of Subjects With Injection Site Adverse Experiences
研究概览
简要总结
This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.
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
- •Healthy females 16 to 23 years of age
- •Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
- •Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)
排除标准
- •No prior receipt of an Human Papillomavirus (HPV) vaccine
- •No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
- •No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
- •No prior history of genital warts or treatment for genital warts
研究组 & 干预措施
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
干预措施: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 (Biological)
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
干预措施: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 (Biological)
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
干预措施: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 (Biological)
Placebo (mcg) (Aluminum Adjuvant) 225
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
干预措施: Placebo (mcg) (Aluminum Adjuvant)225 (Biological)
Placebo (mcg) (Aluminum Adjuvant) 450
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
干预措施: Placebo (mcg) (Aluminum Adjuvant) 450 (Biological)
结局指标
主要结局
Number of Subjects With Injection Site Adverse Experiences
时间窗: Days 1-5 following any vaccination visit
次要结局
- Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)(Through 36 Months)