An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Number of Participants Who Seroconvert to HPV 18.
研究概览
简要总结
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
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 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Girls ages 9 to 15 years (must not yet have had coitarche)
- •Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)
排除标准
- •All Subjects:
- •History of known prior vaccination with an HPV vaccine.
- •Women Ages 16 to 23 Only:
- •Individuals with any prior history of genital warts or treatment for genital warts.
- •Individuals with > 3 lifetime male or female sexual partners.
结局指标
主要结局
Number of Participants Who Seroconvert to HPV 18.
时间窗: Week 4 Postdose 3
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
Number of Participants Who Seroconvert to HPV 6.
时间窗: Week 4 Postdose 3
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Number of Participants Who Seroconvert to HPV 16.
时间窗: Week 4 Postdose 3
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Number of Participants Who Seroconvert to HPV 11.
时间窗: Week 4 Postdose 3
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
次要结局
- Number of Participants With Adverse Experiences(Overall study including 14 calendar days after the last vaccination visit.)