South Australian Meningococcal B Vaccine Herd Immunity Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34,489
- 试验地点
- 2
- 主要终点
- Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
研究概览
简要总结
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.
详细描述
This cluster randomised controlled study will be conducted in the context of funded 4CMenB vaccine offered to all students in years 10, 11, and 12.
Year 10 and 11 students will undergo baseline and 12 months posterior pharyngeal swabs. Year 12 students will undergo baseline posterior pharyngeal swabs only.
Randomisation will take place at the school level and will be stratified by school size ((<60, 60 to 119, and ≥120 students per year level) and school socio-economic status (SES), as measured by the Index of Community Socio-Educational Advantage (ICSEA); (ICSEA <970, 970 to 1020, >1020) For the purposes of the study a school is defined as an educational institution at which students in years 10, 11, 12 physically attend school during the week. All 260 schools in metropolitan and rural SA will be approached to participate in the study. All schools agreeing to participate will be randomised to 4CMenB vaccine in 2017 or 2018. Students at schools randomised to receive the vaccine at baseline will receive the 4CMenB vaccine in 2017. Students at schools randomised to receive the vaccine at the 12 month posterior pharyngeal swab will receive the 4CMenB vaccine in 2018.
Primary Objectives
• Estimate the difference in carriage prevalence of disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Previous anaphylaxis following any component of Bexsero vaccine
- •Previous receipt of meningococcal B vaccine (Bexsero)
- •Known pregnancy
研究组 & 干预措施
Group A
Students within schools randomised to group A will receive two doses of licensed 4CMenB vaccine after baseline oropharyngeal swab with an interval of 1 to 2 months between doses, with the first dose given at the baseline visit in 2017.
干预措施: Licensed 4CMenB vaccine (Biological)
Group B
Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018.
结局指标
主要结局
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
时间窗: 12 months
As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students
次要结局
- Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)(12 months)
- Prevalence of all N. meningitidis genogroups(12 months)
- Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)(12 months)
- Acquisition of all N. meningitidis(12 months)
- Risk factors associated with carriage prevalence of all N. meningitidis(Baseline and 12 months)
- Risk factors associated with carriage prevalence of disease causing N. meningitidis(Baseline and 12 months)
研究者
Helen Marshall
Director, Vaccinology and Immunology Research Trials Unit
University of Adelaide