A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada (H1N1-014VS)
10. Mai 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
1
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
6 Monate und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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).
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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..
Andere Namen:
|
|
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Occurrence of MS
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Occurrence of MS
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Salah Mahmud, MD, PhD, Community Health Sciences, University of Manitoba
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Rao SM, Leo GJ, Ellington L, Nauertz T, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning. Neurology. 1991 May;41(5):692-6. doi: 10.1212/wnl.41.5.692.
- 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.
- Ascherio 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.
- Bansil S, Troiano R, Dowling PC, Cook SD. Measles vaccination does not prevent multiple sclerosis. Neuroepidemiology. 1990;9(5):248-54. doi: 10.1159/000110781.
- Bardage 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.
- Beck 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.
- Canadian 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.
- Confavreux 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.
- Cosby 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.
- Cummings 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. Erratum In: Epidemiol Rev. 2004 Aug 1;160(3):300.
- Currier 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.
- Dean G. How many people in the world have multiple sclerosis? Neuroepidemiology. 1994;13(1-2):1-7. doi: 10.1159/000110351. No abstract available.
- DeStefano 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.
- Dublin 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.
- Elixhauser 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.
- Farez MF, Ysrraelit MC, Fiol M, Correale J. H1N1 vaccination does not increase risk of relapse in multiple sclerosis: a self-controlled case-series study. Mult Scler. 2012 Feb;18(2):254-6. doi: 10.1177/1352458511417253. Epub 2011 Aug 9. No abstract available.
- Fedson DS, Wajda A, Nicol JP, Hammond GW, Kaiser DL, Roos LL. Clinical effectiveness of influenza vaccination in Manitoba. JAMA. 1993 Oct 27;270(16):1956-61. Erratum In: JAMA 1994 May 25;271(20):1578.
- 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.
- Haase AT, Ventura P, Gibbs CJ Jr, Tourtellotte WW. Measles virus nucleotide sequences: detection by hybridization in situ. Science. 1981 May 8;212(4495):672-5. doi: 10.1126/science.7221554.
- Hammerschlag MR, Ke Z, Lu F, Roblin P, Boman J, Kalman B. Is Chlamydia pneumoniae present in brain lesions of patients with multiple sclerosis? J Clin Microbiol. 2000 Nov;38(11):4274-6. doi: 10.1128/JCM.38.11.4274-4276.2000.
- Hardy JR, Holford TR, Hall GC, Bracken MB. Strategies for identifying pregnancies in the automated medical records of the General Practice Research Database. Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):749-59. doi: 10.1002/pds.935.
- Humphries KH, Rankin JM, Carere RG, Buller CE, Kiely FM, Spinelli JJ. Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review? J Clin Epidemiol. 2000 Apr;53(4):343-9. doi: 10.1016/s0895-4356(99)00188-2.
- Kakalacheva K, Lunemann JD. Environmental triggers of multiple sclerosis. FEBS Lett. 2011 Dec 1;585(23):3724-9. doi: 10.1016/j.febslet.2011.04.006. Epub 2011 Apr 7.
- Kelsey JL, Whittemore AS, Evans AS, Thompson WD (1996). Methods in Observational Epidemiology (2nd Edition) (Table 12-15) Oxford University Press.
- Kozyrskyj AL, Mustard CA. Validation of an electronic, population-based prescription database. Ann Pharmacother. 1998 Nov;32(11):1152-7. doi: 10.1345/aph.18117.
- Lix L, Yogendran M, Burchill C, et al., (2006). Defining and Validating Chronic Diseases: An Administrative Data Approach (Winnipeg, Manitoba Centre for Health Policy).
- Mahmud S, Hammond G, Elliott L, Hilderman T, Kurbis C, Caetano P, Van Caeseele P, Kettner J, Dawood M. Effectiveness of the pandemic H1N1 influenza vaccines against laboratory-confirmed H1N1 infections: population-based case-control study. Vaccine. 2011 Oct 19;29(45):7975-81. doi: 10.1016/j.vaccine.2011.08.068. Epub 2011 Aug 30.
- Mahmud SM, Van Caeseele P, Hammond G, Kurbis C, Hilderman T, Elliott L. No association between 2008-09 influenza vaccine and influenza A(H1N1)pdm09 virus infection, Manitoba, Canada, 2009. Emerg Infect Dis. 2012 May;18(5):801-10. doi: 10.3201/eid1805.111596.
- Marrie RA, Yu N, Blanchard J, Leung S, Elliott L. The rising prevalence and changing age distribution of multiple sclerosis in Manitoba. Neurology. 2010 Feb 9;74(6):465-71. doi: 10.1212/WNL.0b013e3181cf6ec0. Epub 2010 Jan 13. Erratum In: Neurology. 2011 Sep 13;77(11):1105.
- Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. doi: 10.1016/S1474-4422(04)00933-0.
- 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.
- McNicholas N, Chataway J. Relapse risk in patients with multiple sclerosis after H1N1 vaccination, with or without seasonal influenza vaccination. J Neurol. 2011 Aug;258(8):1545-7. doi: 10.1007/s00415-011-5944-x. Epub 2011 Feb 19. No abstract available.
- Nortvedt MW, Riise T, Myhr KM, Nyland HI. Quality of life in multiple sclerosis: measuring the disease effects more broadly. Neurology. 1999 Sep 22;53(5):1098-103. doi: 10.1212/wnl.53.5.1098.
- 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.
- Persson I, Granath F, Askling J, Ludvigsson JF, Olsson T, Feltelius N. Risks of neurological and immune-related diseases, including narcolepsy, after vaccination with Pandemrix: a population- and registry-based cohort study with over 2 years of follow-up. J Intern Med. 2014 Feb;275(2):172-90. doi: 10.1111/joim.12150. Epub 2013 Nov 10. Erratum In: J Intern Med. 2017 Jan;281(1):102-104.
- Roberts JD, Poffenroth LA, Roos LL, Bebchuk JD, Carter AO. Monitoring childhood immunizations: a Canadian approach. Am J Public Health. 1994 Oct;84(10):1666-8. doi: 10.2105/ajph.84.10.1666.
- Roberts JD, Roos LL, Poffenroth LA, Hassard TH, Bebchuk JD, Carter AO, Law B. Surveillance of vaccine-related adverse events in the first year of life: a Manitoba cohort study. J Clin Epidemiol. 1996 Jan;49(1):51-8. doi: 10.1016/0895-4356(95)00522-6.
- Roos LL, Mustard CA, Nicol JP, McLerran DF, Malenka DJ, Young TK, Cohen MM. Registries and administrative data: organization and accuracy. Med Care. 1993 Mar;31(3):201-12. doi: 10.1097/00005650-199303000-00002.
- Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):757-63. doi: 10.7326/0003-4819-127-8_part_2-199710151-00064.
- Singh H, Demers AA, Nugent Z, Mahmud SM, Kliewer EV, Bernstein CN. Risk of cervical abnormalities in women with inflammatory bowel disease: a population-based nested case-control study. Gastroenterology. 2009 Feb;136(2):451-8. doi: 10.1053/j.gastro.2008.10.021. Epub 2008 Oct 15.
- Singh H, Mahmud SM, Turner D, Xue L, Demers AA, Bernstein CN. Long-term use of statins and risk of colorectal cancer: a population-based study. Am J Gastroenterol. 2009 Dec;104(12):3015-23. doi: 10.1038/ajg.2009.574. Epub 2009 Oct 6.
- Skarsgard D, Tonita J. Prostate cancer in Saskatchewan Canada, before and during the PSA era. Cancer Causes Control. 2000 Jan;11(1):79-88. doi: 10.1023/a:1008965617078.
- Therneau T M, Grambsch P M (2000). Modeling Survival Data: Extending the Cox Model (New York, Springer).
- Thompson LH, Mahmud SM, Keynan Y, Blanchard JF, Slater J, Dawood M, Fowke K, Van Caeseele P, Becker M. Serological survey of the novel influenza A H1N1 in inner city Winnipeg, Manitoba, 2009. Can J Infect Dis Med Microbiol. 2012 Summer;23(2):65-70. doi: 10.1155/2012/484693.
- Vrethem M, Malmgren K, Lindh J. A patient with both narcolepsy and multiple sclerosis in association with Pandemrix vaccination. J Neurol Sci. 2012 Oct 15;321(1-2):89-91. doi: 10.1016/j.jns.2012.07.025. Epub 2012 Jul 28.
- WHO Collaborating Centre for Drug Statistics Methodology (2002). ATC Index With DDDs (WHO, Oslo, Norway,).
- Bramer GR. International statistical classification of diseases and related health problems. Tenth revision. World Health Stat Q. 1988;41(1):32-6.
- Robinson JR, Young TK, Roos LL, Gelskey DE. Estimating the burden of disease. Comparing administrative data and self-reports. Med Care. 1997 Sep;35(9):932-47. doi: 10.1097/00005650-199709000-00006.
- Zarychanski R, Stuart TL, Kumar A, Doucette S, Elliott L, Kettner J, Plummer F. Correlates of severe disease in patients with 2009 pandemic influenza (H1N1) virus infection. CMAJ. 2010 Feb 23;182(3):257-64. doi: 10.1503/cmaj.091884. Epub 2010 Jan 21.
- Zorzon M, Zivadinov R, Nasuelli D, Dolfini P, Bosco A, Bratina A, Tommasi MA, Locatelli L, Cazzato G. Risk factors of multiple sclerosis: a case-control study. Neurol Sci. 2003 Nov;24(4):242-7. doi: 10.1007/s10072-003-0147-6.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2014
Primärer Abschluss (Tatsächlich)
1. August 2015
Studienabschluss (Tatsächlich)
1. Dezember 2015
Studienanmeldedaten
Zuerst eingereicht
17. Dezember 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Februar 2015
Zuerst gepostet (Schätzen)
20. Februar 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
12. Mai 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Mai 2016
Zuletzt verifiziert
1. November 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 200405 (H2014:019)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Exposed to Arepanrix™ Cohort
-
AstraZenecaAktiv, nicht rekrutierendCOVID-19, SARS-CoV-2Vereinigte Staaten, Belgien, Kanada, Frankreich, Spanien, Dänemark, Thailand, Vietnam, Korea, Republik von, Vereinigtes Königreich, Malaysia, Israel, Taiwan, Australien, Deutschland, Polen, Singapur, Vereinigte Arabische Emirate