Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,409
- 主要终点
- Incidence of Persistent HPV 16 Infection
研究概览
简要总结
Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.
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, unmarried females age 16 to 23 years with intact uteri
- •Not pregnant at enrollment
- •Agreed to use effective contraception through Month 7 of the study
- •A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse
排除标准
- •No prior history of Human Papillomavirus (HPV) vaccination
- •No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
- •No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
结局指标
主要结局
Incidence of Persistent HPV 16 Infection
时间窗: Through Month 48
Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.
Incidence of HPV 16-related CIN1, CIN2 or C1N3
时间窗: Through Month 48
Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.
Serum Anti-HPV 16 Geometric Mean Titers
时间窗: Month 7
The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as "6.0".
次要结局
未报告次要终点