A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand
试验速览
- 阶段
- 不适用
- 入组人数
- 18,000
- 试验地点
- 1
- 主要终点
- HPV infection prevalence
研究概览
简要总结
This is a community intervention effectiveness study in female school students in Thailand.
The study objectives are:
- To demonstrate HPV vaccine effectiveness of Single Dose (SD) by a reduction in vaccine-type HPV prevalence (HPV 16 and HPV 18) at Year 2 and Year 4 post vaccination compared to unvaccinated same grade female students
- To demonstrate that HPV vaccine effectiveness of SD and two-dose (2D) regimens are similar by comparing reductions in vaccine type prevalence at Year 2 and Year 4 post vaccination compared with the baseline surveys in the two provinces
详细描述
The study will investigate the effectiveness of a SD of HPV vaccine through the conduct of a regional effectiveness study in Thailand.
The study will be conducted in schools and district hospitals from the two selected provinces (Udon Thani and Buriram)
The study design includes 4 distinct and independent components:
- vaccination, 2)baseline cross-sectional survey, 3,4)sequential cross-sectional surveys for impact assessments at Year 2 and Year 4 post vaccination.
- Vaccination: The target population is represented by all Grade 8 female students in the two provinces. All enrolled students will receive either SD (Udon Thani) or 2D (Buriram). A subset (N=200/province) of Grade 8 female students in each province will be selected for a blood collection before vaccination for assessment of vaccine immunogenicity.
- Surveys (baseline, Year 2 and Year 4 impact surveys): Target populations of are a subset of female students of Grades 10 High school (HS)/year 1 Vocational School (VS) and Grade 12 HS/year 3 VS from all schools in the two provinces and the sampling unit is an individual. Urine collection will be performed to assess HPV infection by DNA PCR and for genotyping of positive samples. A subset of students (N=200 per province) will be randomly selected for each of the Year 2 and Year 4 surveys for blood collection for assessment of vaccine immunogenicity.
- Demographics and sexual behavior questionnaire will be collected from all students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •A. Grade 8 (Mathayom 2):
- •Female students with identification card
- •Less than 15 years of age
- •Parent or guardian consent for vaccination and blood collection as applicable Participant assent for vaccination, questionnaire, and blood collection as applicable
- •B. Baseline survey (Grade 10 / year 1, Grade 12 / year 3)
- •Female students with identification card Participant assent for questionnaire and urine collection
- •C. Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)
- •Female students with identification card
- •Parent or guardian consent for blood collection as applicable
- •Participant assent for questionnaire, urine and blood collection from those vaccinated at Grade 8 as applicable
排除标准
- •A. Grade 8 (Mathayom 2):
- •Students who already received HPV vaccination
- •Reported pregnancy
- •Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
- •B. Baseline survey (Grade 10 / year 1, Grade 12 / year 3)
- •Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
- •C. Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)
- •Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
研究组 & 干预措施
Cross-sectional baseline survey
This are will collect behavioral questionnaire and urine in Grade 10 high school and Year 1 vocational school and Grade 12 high school and Year 3 Vocational school female students
Single Dose HPV vaccination
Grade 8 female students from Udon Thani Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Single Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium)
干预措施: Bivalent HPV vaccine CERVARIX® (Biological)
Two-dose HPV vaccination
Grade 8 female students from Buriram Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Two-Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium)
干预措施: Bivalent HPV vaccine CERVARIX® (Biological)
Cross-sectional survey at Year 2
This arm will collect behavioral questionnaire, urine and blood in Grade 10 high school and Year 1 vocational school female students
Cross-sectional survey at Year 4
Cross-sectional survey at Year 4 post vaccination
结局指标
主要结局
HPV infection prevalence
时间窗: Year 4, four years post vaccination
HPV DNA PCR in urine
Identification of HPV circulating strains
时间窗: Year 4, four years post vaccination
HPV genotyping on urine positive samples
HPV infection prevalence
时间窗: Baseline survey (unvaccinated students) during the first year of the study
HPV DNA PCR in urine
HPV infection prevalence
时间窗: Year 2, two years post vaccination
HPV DNA PCR in urine
Identification of HPV circulating strains
时间窗: Baseline survey (unvaccinated students) during the first year of the study
HPV genotyping on urine positive samples
Identification of HPV circulating strains
时间窗: Year 2, two years post vaccination
HPV genotyping on urine positive samples
次要结局
- HPV type-specific antibody response prior and post vaccination(Prior vaccination and at Year 2 and Year 4 Post vaccination)