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

Multiple Sclerosis Clinical Trial

— H1N1-014VS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02367222
• Other study ID #: 200405 (H2014:019)
• Status: Active, not recruiting
• Phase: N/A
• First received: December 17, 2014
• Last updated: November 12, 2015
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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..
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	GlaxoSmithKline

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of MS	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)	No
Secondary	Occurrence of MS	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)	No
Secondary	Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS	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)	No
Secondary	Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS	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)	No