Multiple SclerosisH1N1-014VSNCT02367222
A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
An observational study of Multiple Sclerosis, run by University of Manitoba.
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exposed to Arepanrix™ Cohort and Unexposed to Arepanrix™ Cohort
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- The entire population of Manitoba is considered for inclusion.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Exposed to Arepanrix™ Cohort, Unexposed to Arepanrix™ Cohort
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to Arepanrix™ CohortOther
Also called Database collection and analysis
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™ CohortOther
Also called Database collection and analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Exposed to Arepanrix™ Cohort | |
| 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). Receives: Other: Unexposed to Arepanrix™ Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 September 2009 to 15 March 2010 (up to 6 months)
Secondary outcomes (3)
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.
Measured: 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
During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort.
Measured: 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
From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort.
Measured: 15 September 2009 to 31 December 2012 (up to 39 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Salah Mahmud, MD, PhD, Principal investigator, Community Health Sciences, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367222
- Sponsor's protocol ID
- 200405 (H2014:019)
- Acronym
- H1N1-014VS
- Status last verified
- Nov 2015
- First submitted
- 17 Dec 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ascherio A, Munger KL, Lunemann JD. The initiation and prevention of multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):602-12. doi: 10.1038/nrneurol.2012.198. Epub 2012 Oct 9.
PubMed 23045241Ascherio A, Zhang SM, Hernan MA, Olek MJ, Coplan PM, Brodovicz K, Walker AM. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001 Feb 1;344(5):327-32. doi: 10.1056/NEJM200102013440502.
PubMed 11172163Bansil S, Troiano R, Dowling PC, Cook SD. Measles vaccination does not prevent multiple sclerosis. Neuroepidemiology. 1990;9(5):248-54. doi: 10.1159/000110781.
PubMed 2087249Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ. 2011 Oct 12;343:d5956. doi: 10.1136/bmj.d5956.
PubMed 21994316Beck CA, Metz LM, Svenson LW, Patten SB. Regional variation of multiple sclerosis prevalence in Canada. Mult Scler. 2005 Oct;11(5):516-9. doi: 10.1191/1352458505ms1192oa.
PubMed 16193887Canadian Institute for Health Information (2006). Canadian Classification of Health Interventions (Ottawa, Ontario, Canada).
Casetta I, Granieri E, Malagu S, Tola MR, Paolino E, Caniatti LM, Govoni V, Monetti VC, Fainardi E. Environmental risk factors and multiple sclerosis: a community-based, case-control study in the province of Ferrara, Italy. Neuroepidemiology. 1994;13(3):120-8. doi: 10.1159/000110369.
PubMed 8015665Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S; Vaccines in Multiple Sclerosis Study Group. Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. N Engl J Med. 2001 Feb 1;344(5):319-26. doi: 10.1056/NEJM200102013440501.
PubMed 11172162Cosby SL, McQuaid S, Taylor MJ, Bailey M, Rima BK, Martin SJ, Allen IV. Examination of eight cases of multiple sclerosis and 56 neurological and non-neurological controls for genomic sequences of measles virus, canine distemper virus, simian virus 5 and rubella virus. J Gen Virol. 1989 Aug;70 ( Pt 8):2027-36. doi: 10.1099/0022-1317-70-8-2027.
PubMed 2769228Cummings P, McKnight B, Greenland S. Matched cohort methods for injury research. Epidemiol Rev. 2003;25:43-50. doi: 10.1093/epirev/mxg002. No abstract available.
PubMed 12923989Currier RD, Meydrech EF, Currier MM. Measles vaccination has had no effect on the occurrence of multiple sclerosis. Arch Neurol. 1996 Dec;53(12):1216. doi: 10.1001/archneur.1996.00550120018007. No abstract available.
PubMed 8970447Dean G. How many people in the world have multiple sclerosis? Neuroepidemiology. 1994;13(1-2):1-7. doi: 10.1159/000110351. No abstract available.
PubMed 8190200DeStefano F, Verstraeten T, Jackson LA, Okoro CA, Benson P, Black SB, Shinefield HR, Mullooly JP, Likosky W, Chen RT; Vaccine Safety Datalink Research Group, National Immunization Program, Centers for Disease Control and Prevention. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003 Apr;60(4):504-9. doi: 10.1001/archneur.60.4.504.
PubMed 12707063Dublin S, Jackson ML, Nelson JC, Weiss NS, Larson EB, Jackson LA. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ. 2009 Jun 16;338:b2137. doi: 10.1136/bmj.b2137.
PubMed 19531550Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.
PubMed 9431328
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Retrospective Database Analysis to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada
- ClinicalTrials.gov ID
- NCT02367222
- Acronym / sponsor ID
- H1N1-014VS / 200405 (H2014:019)
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to Arepanrix™ Cohort | – | Other: Exposed to Arepanrix™ CohortAll 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). |
| Unexposed to Arepanrix™ Cohort | – | Other: Unexposed to Arepanrix™ CohortAll 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). |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- The entire population of Manitoba is considered for inclusion.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed to Arepanrix™ CohortAlso: Database collection and analysisDemographic 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 | Exposed to Arepanrix™ Cohort |
| Unexposed to Arepanrix™ CohortAlso: Database collection and analysisDemographic 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 | Unexposed to Arepanrix™ Cohort |
Primary outcome
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.
3 secondary outcomes
Occurrence of MS
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Results publication: PubMed 23045241Ascherio A, Munger KL, Lunemann JD. The initiation and prevention of multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):602-12. doi: 10.1038/nrneurol.2012.198. Epub 2012 Oct 9.
- Results publication: PubMed 11172163Ascherio A, Zhang SM, Hernan MA, Olek MJ, Coplan PM, Brodovicz K, Walker AM. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001 Feb 1;344(5):327-32. doi: 10.1056/NEJM200102013440502.
- Results publication: PubMed 2087249Bansil S, Troiano R, Dowling PC, Cook SD. Measles vaccination does not prevent multiple sclerosis. Neuroepidemiology. 1990;9(5):248-54. doi: 10.1159/000110781.
- Results publication: PubMed 21994316Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ. 2011 Oct 12;343:d5956. doi: 10.1136/bmj.d5956.
- Results publication: PubMed 16193887Beck CA, Metz LM, Svenson LW, Patten SB. Regional variation of multiple sclerosis prevalence in Canada. Mult Scler. 2005 Oct;11(5):516-9. doi: 10.1191/1352458505ms1192oa.
- Results publicationCanadian Institute for Health Information (2006). Canadian Classification of Health Interventions (Ottawa, Ontario, Canada).
- Results publication: PubMed 8015665Casetta I, Granieri E, Malagu S, Tola MR, Paolino E, Caniatti LM, Govoni V, Monetti VC, Fainardi E. Environmental risk factors and multiple sclerosis: a community-based, case-control study in the province of Ferrara, Italy. Neuroepidemiology. 1994;13(3):120-8. doi: 10.1159/000110369.
- Results publication: PubMed 11172162Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S; Vaccines in Multiple Sclerosis Study Group. Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. N Engl J Med. 2001 Feb 1;344(5):319-26. doi: 10.1056/NEJM200102013440501.
- Results publication: PubMed 2769228Cosby SL, McQuaid S, Taylor MJ, Bailey M, Rima BK, Martin SJ, Allen IV. Examination of eight cases of multiple sclerosis and 56 neurological and non-neurological controls for genomic sequences of measles virus, canine distemper virus, simian virus 5 and rubella virus. J Gen Virol. 1989 Aug;70 ( Pt 8):2027-36. doi: 10.1099/0022-1317-70-8-2027.
- Results publication: PubMed 12923989Cummings P, McKnight B, Greenland S. Matched cohort methods for injury research. Epidemiol Rev. 2003;25:43-50. doi: 10.1093/epirev/mxg002. No abstract available.
- Results publication: PubMed 8970447Currier RD, Meydrech EF, Currier MM. Measles vaccination has had no effect on the occurrence of multiple sclerosis. Arch Neurol. 1996 Dec;53(12):1216. doi: 10.1001/archneur.1996.00550120018007. No abstract available.
- Results publication: PubMed 8190200Dean G. How many people in the world have multiple sclerosis? Neuroepidemiology. 1994;13(1-2):1-7. doi: 10.1159/000110351. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Mahmud, MD, PhD principal investigator
Community Health Sciences, University of Manitoba
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of MS (time frame: 15 September 2009 to 15 March 2010 (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02367222, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016; AzTrials last refreshed its copy on 3 Nov 2026.