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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposed to Arepanrix™ Cohort | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of MS | During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort. | 15 September 2009 to 15 March 2010 (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of MS | From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Salah Mahmud, MD, PhD | Community Health Sciences, University of Manitoba | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23045241 | Result | Ascherio A, Munger KL, Lunemann JD. The initiation and prevention of multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):602-12. doi: 10.1038/nrneurol.2012.198. Epub 2012 Oct 9. | |
| 11172163 | Result | Ascherio A, Zhang SM, Hernan MA, Olek MJ, Coplan PM, Brodovicz K, Walker AM. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001 Feb 1;344(5):327-32. doi: 10.1056/NEJM200102013440502. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
|
| Unexposed to Arepanrix™ Cohort | 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. |
|
|
During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort. |
| 15 September 2009 to 15 March 2010 (up to 3 months) |
| Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS | From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort. | 15 September 2009 to 31 December 2012 (up to 39 months) |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |