Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms
研究概览
简要总结
A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.
详细描述
The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9-10-year-old girls and boys
排除标准
- •previously received an HPV vaccine
- •immunosuppressed
- •known allergy to a vaccine component
研究组 & 干预措施
Immunogenicity two doses of Gardasil-9
Subjects will receive two doses of Gardasil-9
干预措施: Immunogenicity two doses of Gardasil-9 (Biological)
Immunogenicity Cervarix and Gardasil-9
Subjects will receive a dose Cervarix and a dose Gardasil-9
干预措施: Immunogenicity Cervarix and Gardasil-9 (Biological)
结局指标
主要结局
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms
时间窗: 36 months post-second dose of vaccine
A Luminex Total IgG assay will be used to assess the presence of antibodies and antibody titers to 9 HPV genotypes included in the Gardasil-9 vaccine. Luminex Units will be used for the antibody titers assessment.
次要结局
- Comparison of tolerability profile of Gardasil-9 and Cervarix(During 5 days after each vaccine dose administration.)