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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367222
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Manitoba

Study Description
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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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Exposed to Arepanrix™ Cohort Other: Unexposed to Arepanrix™ Cohort

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 Design
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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
Study Start Date : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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 Name: Database collection and analysis


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367222


Sponsors and Collaborators
University of Manitoba
GlaxoSmithKline
Investigators
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Principal Investigator: Salah Mahmud, MD, PhD Community Health Sciences, University of Manitoba
More Information
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Publications of Results:
Canadian Institute for Health Information (2006). Canadian Classification of Health Interventions (Ottawa, Ontario, Canada).
Fleiss J L Levin B, Paik M C. (2003). Statistical Methods for Rates and Proportions (3rd ed.) (Formulas 3.18 &3.19). New York: John Wiley & Sons.
Kelsey JL, Whittemore AS, Evans AS, Thompson WD (1996). Methods in Observational Epidemiology (2nd Edition) (Table 12-15) Oxford University Press.
Lix L, Yogendran M, Burchill C, et al., (2006). Defining and Validating Chronic Diseases: An Administrative Data Approach (Winnipeg, Manitoba Centre for Health Policy).
MCHP Guidelines for Public and Private Sponsorship of Research Projects Accessing the Population Health Data Repository (2011); http://umanitoba.ca/faculties/medicine/units/community_health_sciences/departmental_units/mchp/protocol/media/Private_Sector_Sponsorship_Guidelines.pdf.
OpenEpi: Open Source Epidemiologic Statistics for Public Health, Version 3.01, Released April 4 and revised April 6, 2013, http://www.openepi.com/v37/SampleSize/SSPropor.htm.
Parsons L S (2001). Reducing bias in a propensity score matched-pair sample using greedy matching techniques. Paper presented at: Proceedings of the Twenty-sixth Annual SAS Users group international conference (SAS Institute, Inc.); pp. 214-26.
Therneau T M, Grambsch P M (2000). Modeling Survival Data: Extending the Cox Model (New York, Springer).
WHO Collaborating Centre for Drug Statistics Methodology (2002). ATC Index With DDDs (WHO, Oslo, Norway,).

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02367222    
Other Study ID Numbers: 200405 (H2014:019)
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases