NCT00956553已完成4 期
A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
研究概览
简要总结
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
详细描述
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 13 and 15 years at the time of the first immunisation
- •No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- •Written informed consent obtained from parent or guardian of subject
排除标准
- •Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
- •Breast-feeding mothers
- •Allergic to vaccine components
研究组 & 干预措施
Gardasil
Active Comparator
Three doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.
干预措施: Gardasil (Biological)
Cervarix
Active Comparator
Three doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.
干预措施: Cervarix (Biological)
结局指标
主要结局
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
时间窗: 18 months from enrollment
次要结局
- Determine differences in vaccine formulation and their impact on cross protection.(24 months from enrollment)
研究者
研究点 (3)
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