NCT02367222

A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada

An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Exposed to Arepanrix™ Cohort	Demographic characteristics such as age, sex, area of residence, socio-economic status; medical history such as comorbidities, immune status, vaccine indication, receipt of other vaccines or medications and frequency of healthcare contacts, as well as information on pregnancy status and pre-existing conditions will be collected..
OTHER	Unexposed to Arepanrix™ Cohort	Demographic characteristics such as age, sex, area of residence, socio-economic status; medical history such as comorbidities, immune status, vaccine indication, receipt of other vaccines or medications and frequency of healthcare contacts, as well as information on pregnancy status and pre-existing conditions will be collected.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2015-02-20
• Last updated: 2016-05-12