A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada (H1N1-014VS)

University of Manitoba

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Exposed to Arepanrix™ Cohort; Other: Unexposed to Arepanrix™ Cohort

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02367222

200405 (H2014:019)

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 estimated patient

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1 participants in 2 patient groups

Exposed to Arepanrix™ Cohort

Description:

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).

Treatment:

Other: Exposed to Arepanrix™ Cohort

Unexposed to Arepanrix™ Cohort

Description:

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).

Treatment:

Other: Unexposed to Arepanrix™ Cohort