NCT03158220已完成3 期
An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,212
- 试验地点
- 24
- 主要终点
- Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
研究概览
简要总结
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •good physical health
排除标准
- •history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
- •history of HPV-related condition
- •history of known prior vaccination with an HPV vaccine
- •user of recreational or illicit drugs
- •history of severe allergic reaction, including known allergy to any vaccine component
- •immunocompromised
- •history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
- •has thrombocytopenia or other coagulation disorder
- •concurrently enrolled in a clinical study of investigational agent
结局指标
主要结局
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
时间窗: 4 weeks post vaccination 3 (Month 7)
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
次要结局
- Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event(Up to 5 days post any vaccination)
- Percentage of Participants With Elevated Temperature (Fever)(Up to 5 days post any vaccination)
- Percentage of Participants That Experienced at Least 1 Adverse Event (AE)(Up to 1 month post vaccination 3 (up to 7 months))
- Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.(Up to 1 month post vaccination 3 (up to 7 months))
- Percentage of Participants That Reported at Least 1 Systemic Adverse Event(Up to 15 days post any vaccination)
- Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types(4 weeks post vaccination 3 (Month 7))
研究者
研究点 (24)
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