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
- 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.
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)