Work Package 4: HPV Vaccination of Women in Screening Ages
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- number of vaccinated patients
研究概览
简要总结
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.
详细描述
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.
Safety data and HPV vaccine compliance will be assessed.
A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.
Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women within the age range of 25-45
- •attending cervical cancer screening
排除标准
- •previous history of HPV vaccine administration
研究组 & 干预措施
women attending for cervical cancer screening
干预措施: questionnaire (Other)
women attending for cervical cancer screening
干预措施: Gardasil vaccine (Biological)
women attending for cervical cancer screening
干预措施: Cervarix® (Biological)
结局指标
主要结局
number of vaccinated patients
时间窗: up to 3 years
次要结局
未报告次要终点