An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Occurrence of MS
研究概览
简要总结
The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (MS) in Manitoba, Canada.
详细描述
This observational, retrospective, propensity-score matched cohort study using the Manitoba Immunization Monitoring System (MIMS) and the hospital, physician, and prescription claims databases of the Manitoba Health (MH) Database System will assess if Arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (MS) and other demyelinating conditions not ultimately leading to a multiple sclerosis diagnosis in Manitoba, Canada.
The data will be collected form the following linked databases:
- Manitoba Health (MH) administrative databases
- Manitoba Immunization Monitoring System (MIMS)
- Manitoba Health Population Registry (MHPR)
- Drug Program Information Network (DPIN)
- Hospital Abstract Database
- The Medical Services database
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The entire population of Manitoba is considered for inclusion.
排除标准
- •Individuals less than or equal to 6 months of age;
- •Having less than one year of insurance coverage before the enrolment period;
- •Not registered with MH during the enrolment period;
- •Physician or hospitalization records indicating a diagnosis of any demyelinating condition between 1971 (earliest year for which information is available) and the index date.
结局指标
主要结局
Occurrence of MS
时间窗: 15 September 2009 to 15 March 2010 (up to 6 months)
During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort.
次要结局
- Occurrence of MS(15 September 2009 to 31 December 2012 (up to 39 months))
- Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS(15 September 2009 to 31 December 2012 (up to 39 months))