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

May 10, 2016 updated by: University of Manitoba

An Observational Retrospective Database Analysis 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: Exposed 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..
Other Names:
  • Database collection and analysis
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).
Other: Unexposed 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.
Other Names:
  • Database collection and analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 September 2009 to 15 March 2010 (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
15 September 2009 to 31 December 2012 (up to 39 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Salah Mahmud, MD, PhD, Community Health Sciences, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200405 (H2014:019)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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