Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 760
- 试验地点
- 2
- 主要终点
- The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45
研究概览
简要总结
To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 12-45 who willing to do HPV test check-up.
- •Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
- •Based on clinical judgment, the participant with underlying chronic disease who has stable and well-controlled medical conditions.
排除标准
- •Participant with history of total hysterectomy and loop electrosurgical excision procedure.
- •Participant who received 3 doses HPV vaccine.
- •Any condition that might confound the interpretation of vaccine effectiveness by investigator
结局指标
主要结局
The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45
时间窗: 1 visit (1 day)
Estimation of overall vaccine effectiveness For the planned analyses, the log odds of disease for individuals in matched sets will be modelled using the following conditional logistic model:Model 1 : Log (oddcase) = α¬i + β e(HPV_vaccination) + β1(cov_1) +β2(cov_2) + ... + βk(cov_k)where αi is the stratum-specific constant term for each matched set, βe is the parameter coefficient for the exposure of interest (receipt of HPV vaccine), and β1 through βk are the parameter coefficients for each covariate included in the model to control for confounding. Our modelling strategy will be to create models that always contain the exposure variable of interest (receipt of HPV vaccine) and additional covariates as needed.
次要结局
未报告次要终点
研究者
Punnee Pitisuttithum
Professor Emeritus
Mahidol University