Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 903
- 试验地点
- 1
- 主要终点
- Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
研究概览
简要总结
To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.
详细描述
OBJECTIVES:
Primary objective:
To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
Secondary objectives:
- To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
- To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing:
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
- 11 Years 至 13 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •11-13 years of age.
- •Signed informed consent form (both parent's & daughter's signature).
- •Good health status.
- •Able to comply with trial protocol.
- •Plans to stay at current school for duration of study.
排除标准
- •Prior HPV vaccination
- •Pregnant or lactating or intends to become pregnant during study period.
- •Apparent moderate or severe acute illness.
- •Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
- •Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
- •Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past.
- •Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
研究组 & 干预措施
0,6,12 month vaccination schedule
干预措施: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological)
0,12,24 month vaccination schedule
干预措施: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological)
0,2,6 month vaccination schedule
干预措施: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological)
0,3,9 month vaccination schedule
干预措施: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological)
结局指标
主要结局
Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
时间窗: 25 months
Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
时间窗: 25 months
次要结局
- Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.(25 months)
- Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.(25 months)