200405 - An observational retrospective database analysis to estimate the risk of Multiple Sclerosis (MS) following vaccination with Arepanrix™ in Manitoba, Canada

Study identification

• EU PAS number:
  EUPAS6817
• Study ID:
  31668
• Official title and acronym:
  200405 - An observational retrospective database analysis to estimate the risk of Multiple Sclerosis (MS) following vaccination with Arepanrix™ in Manitoba, Canada
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009 H1N1 influenza pandemic was associated with an increased risk of multiple sclerosis 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 H1N1 influenza 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 vaccinated cohort will comprise adults and children greater than 6 months of age (at the time of vaccination) who normally reside in Manitoba with a MIMS record for pandemic H1N1 influenza vaccination between September 15, 2009 and March, 15, 2010. Individuals with MIMS records for Trivalent Inactivated seasonal influenza Vaccine (TIV) during this period will account for potential confounding or effect modification by seasonal influenza vaccination. Individuals with no records of H1N1 or seasonal influenza vaccination will constitute the unvaccinated cohort. Matching will be performed using propensity scores. An MS case will be defined by ≥3 hospital, physician or prescription claims for MS using the International Classification of Diseases (ICD9/10) codes to define a case of MS. The date of diagnosis of MS will be considered the date of the first medical contact for any of the MS diagnostic codes.
• Study status:
  Finalised

Research institutions and networks

Institutions

Community Health Sciences, University of Manitoba

Study timelines

Date when funding contract was signed

Actual:05/08/2014

Study start date

Actual:30/09/2014

Date of final study report

Actual:07/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)