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Completed

NCT Number: NCT02367222

A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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..

Other names: Database collection and analysis

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.

Other names: Database collection and analysis

Primary outcomes

  1. Occurrence of MS

    Time frame: 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 outcomes

  1. Occurrence of MS

    Time frame: 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.

  2. Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS

    Time frame: 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.

  3. Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada

Acronym: H1N1-014VS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2015
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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