Multiple Sclerosis
Conditions
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
Interventions
OTHERExposed 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..
OTHERUnexposed 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.
Sponsors
GlaxoSmithKline
University of Manitoba
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 15 March 2010 (up to 3 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. |
Outcome results
None listed