V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
研究概览
简要总结
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
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
- 9 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Virginal Female Subject Aged 9 To 17 Years
排除标准
- •Male Subject
结局指标
主要结局
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
时间窗: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
时间窗: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
时间窗: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
时间窗: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
次要结局
- HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series(24 month after completed vaccination series (Month 30))