A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,590
- 试验地点
- 5
- 主要终点
- Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
研究概览
简要总结
This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.
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
- 9 Years 至 19 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Is a healthy Chinese male.
- •Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose).
排除标准
- •Has a history of known prior vaccination with an HPV vaccine.
- •Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
- •Has a history of severe allergic reaction that required medical intervention.
- •Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
- •Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- •Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
- •Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
研究组 & 干预措施
9 to 19 Years Old: Day 1, Months 2 and 6
Chinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6
干预措施: 9vHPV vaccine (Biological)
9 to 14 Years Old: Day 1, and Month 6
Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6
干预措施: 9vHPV vaccine (Biological)
9 to 14 Years Old: Day 1 and Month 12
Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12
干预措施: 9vHPV vaccine (Biological)
结局指标
主要结局
Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
时间窗: Up to Month 13
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
时间窗: Up to 72 months
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
时间窗: Up to 72 months
cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.
次要结局
- cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine(Up to Month 13)
- Percentage of participants experiencing serious AEs (SAEs)(Up to 72 months)
- IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose(Up to 72 months)
- Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose(Up to Month 13)
- IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine(Up to Month 13)
- Percentage of participants experiencing solicited injection-site adverse events (AEs),(Day 1 through Day 8 following any study vaccination)
- IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine(Up to 72 months)
- Percentage of participants experiencing solicited systemic AEs(Day 1 through Day 8 following any study vaccination)