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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Unexposed to Arepanrix™ Cohort; Other: Exposed to Arepanrix™ Cohort

• Registration Number: NCT02367222
• Lead Sponsor: University of Manitoba

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-20
• Primary Completion: 2015-08
• Status Verified: 2015-11
• Study Completion: 2015-12
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• The entire population of Manitoba is considered for inclusion.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unexposed to Arepanrix™ Cohort	Unexposed to Arepanrix™ Cohort	All individuals registered with Manitoba Health (MH) during the study period but with no MIMS record for H1N1 (Arepanrix™) and seasonal influenza vaccination during the influenza season 2009/2010 (15 September 2009 to 15 March 2010).
Exposed to Arepanrix™ Cohort	Exposed to Arepanrix™ Cohort	All individuals with Manitoba Immunization Monitoring System (MIMS) record of H1N1 (Arepanrix™) and/or seasonal influenza vaccination during the influenza season 2009/2010 (15 September 2009 to 15 March 2010).

Primary Outcome Measures

Name	Time	Method
Occurrence of MS	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of MS	15 September 2009 to 31 December 2012 (up to 39 months)	From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort.
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)	From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort.