A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
NCT ID: NCT02367222
Last Updated: 2016-05-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
1 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-08-31
Study Completion Date
2015-12-31
Brief Summary
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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.
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Detailed Description
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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
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
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Multiple Sclerosis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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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).
Exposed to Arepanrix™ Cohort
Intervention Type
OTHER
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..
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).
Unexposed to Arepanrix™ Cohort
Intervention Type
OTHER
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.
Interventions
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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..
Intervention Type
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.
Intervention Type
OTHER
Other Intervention Names
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Database collection and analysis
Database collection and analysis
Eligibility Criteria
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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.
* 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.
Minimum Eligible Age
6 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Sponsor Role
collaborator
University of Manitoba
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Salah Mahmud, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Community Health Sciences, University of Manitoba
References
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Other Identifiers
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200405 (H2014:019)
Identifier Type: -
Identifier Source: org_study_id
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