EUCTR2009-011617-25-PL进行中（未招募）1 期
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, andManufacturing Consistency of a Multivalent Human Papillomavirus (HPV)L1 Virus-Like Particle (VLP) Vaccine Administered in Preadolescents andAdolescents (9 to 15 year olds), with a Comparison to Young Women (16 to26 year olds). - Immunogenicity, Tolerability, and Manufacturing Consistency study of a Multivalent HPV, VLP vaccine.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject was enrolled in Protocol 002 between 9 and 15 years of age and
- •received 3 doses of 9-valent HPV L1 VLP vaccine.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4022
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who are concurrently enrolled in clinical studies that would
- •involve or interfere with the collection of genital specimens.
研究者
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进行中（未招募）
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A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 year olds) with a Comparison to Young Women (16 to 26 year olds)Cervical CancersVulvar CancerVaginal CancerGenital LesionsPAP Test AbnormalitiesHPV InfectionsMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862EUCTR2009-011617-25-Outside-EU/EEAMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
已完成
不适用
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)PER-081-09MERCK SHARP & DOHME PERU S.R.L.,