Clinical trial NCT02367222: A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
Official title: An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2015-02-20
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children above 6 months of age (at the time of vaccination) who normally reside in Manitoba, Canada and who had been registered with MH during the study period.

To ensure sufficient historical data, all participants will be required to have at least one year of insurance coverage before the study period (15 September 2009 to 15 March 2010).

Brief 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

Eligibility criteria: Inclusion Criteria:

* The entire population of Manitoba is considered for inclusion.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Occurrence of MS
timeFrame: 15 September 2009 to 15 March 2010 (up to 6 months)
Secondary outcomes:
measure: Occurrence of MS
timeFrame: 15 September 2009 to 31 December 2012 (up to 39 months)
measure: Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS
timeFrame: 15 September 2009 to 15 March 2010 (up to 3 months)
measure: Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS
timeFrame: 15 September 2009 to 31 December 2012 (up to 39 months)
Other outcomes:
Locations:
Study officials:
affiliation: Community Health Sciences, University of Manitoba
name: Salah Mahmud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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