A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada (H1N1-014VS)
10. maj 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 måneder og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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).
|
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..
Andre navne:
|
|
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).
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of MS
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of MS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Salah Mahmud, MD, PhD, Community Health Sciences, University of Manitoba
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2014
Primær færdiggørelse (Faktiske)
1. august 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
17. december 2014
Først indsendt, der opfyldte QC-kriterier
12. februar 2015
Først opslået (Skøn)
20. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. maj 2016
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 200405 (H2014:019)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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