A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,518
- 主要终点
- Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
研究概览
简要总结
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
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
- None
入排标准
- 年龄范围
- 9 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
- •Boys and Girls 9 to 14 Years:
- •Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
- •Women 16 to 26 Years:
- •Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- •A lifetime history of 0 to 4 male and/or female sexual partners
排除标准
- •All Participants:
- •Known allergy to any vaccine component
- •History of severe allergic reaction that required medical intervention
- •Thrombocytopenia or any coagulation disorder
- •Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- •Currently immunocompromised, or been diagnosed with immunodeficiency
- •Had a splenectomy
- •Receiving or has received immunosuppressive therapies within the last year
- •Received any immunoglobulin product or blood-derived product within 3 months
- •Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
结局指标
主要结局
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
时间窗: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
次要结局
- Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
- Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen(4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))