A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada (H1N1-014VS)
10 maggio 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Osservativo
Iscrizione (Anticipato)
1
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
6 mesi e precedenti (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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).
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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).
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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..
Altri nomi:
|
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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).
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Occurrence of MS
Lasso di tempo: 15 September 2009 to 15 March 2010 (up to 6 months)
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During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort.
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15 September 2009 to 15 March 2010 (up to 6 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Occurrence of MS
Lasso di tempo: 15 September 2009 to 31 December 2012 (up to 39 months)
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From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort.
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15 September 2009 to 31 December 2012 (up to 39 months)
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Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS
Lasso di tempo: 15 September 2009 to 15 March 2010 (up to 3 months)
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During the period of 1 year following administration of Arepanrix™ among an exposed cohort and during an equivalent time period in the unexposed cohort.
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15 September 2009 to 15 March 2010 (up to 3 months)
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Occurrence of demyelinating events which do not ultimately lead to a diagnosis of MS
Lasso di tempo: 15 September 2009 to 31 December 2012 (up to 39 months)
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From administration of Arepanrix™ until 31 December 2012, among an exposed cohort and during an equivalent time period in the unexposed cohort.
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15 September 2009 to 31 December 2012 (up to 39 months)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Salah Mahmud, MD, PhD, Community Health Sciences, University of Manitoba
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2014
Completamento primario (Effettivo)
1 agosto 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
17 dicembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
12 febbraio 2015
Primo Inserito (Stima)
20 febbraio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
12 maggio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 maggio 2016
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 200405 (H2014:019)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Exposed to Arepanrix™ Cohort
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ConvaTec Inc.Completato
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LifeCellTerminatoMastectomia e ricostruzione mammariaFrancia, Germania, Regno Unito
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AstraZenecaAttivo, non reclutanteCOVID-19, SARS-CoV-2Stati Uniti, Belgio, Canada, Francia, Spagna, Danimarca, Tailandia, Vietnam, Corea, Repubblica di, Regno Unito, Malaysia, Israele, Taiwan, Australia, Germania, Polonia, Singapore, Emirati Arabi Uniti