Risk of Guillain-Barré syndrome following pandemic influenza A(H1N1) 2009 vaccination in Germany

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 11, 2014, Pages 1192-1204

  Prestel, Jürgen ^a   Volkers, Peter ^a   Mentzer, Dirk ^a   Lehmann, Helmar C ^b,c   Hartung, Hans Peter ^b   Keller Stanislawski, Brigitte ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

^b HEINRICH HEINE UNIVERSITY   (Germany)

^c UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

Author keywords

Guillain Barr syndrome; Pandemic influenza vaccination; Pharmacoepidemiology; Self controlled case series

Indexed keywords

INFLUENZA VACCINE;

ADOLESCENT; ADULT; AGE; AGED; CHEMICALLY INDUCED; CHILD; COMORBIDITY; EPIDEMIOLOGY; FEMALE; GERMANY; GUILLAIN BARRE SYNDROME; HUMAN; INCIDENCE; INFLUENZA A VIRUS (H1N1); INFLUENZA, HUMAN; MALE; MIDDLE AGED; MILLER FISHER SYNDROME; PRESCHOOL CHILD; PROSPECTIVE STUDY; SEX DIFFERENCE; TIME; VERY ELDERLY;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; COMORBIDITY; CONFOUNDING FACTORS (EPIDEMIOLOGY); EPIDEMIOLOGIC STUDIES; FEMALE; GERMANY; GUILLAIN-BARRE SYNDROME; HUMANS; INCIDENCE; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; MILLER FISHER SYNDROME; PROSPECTIVE STUDIES; SEX FACTORS; TIME FACTORS;

EID: 84920270851     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3638     Document Type: Article

References (44)

1. Kieseier BC, Kiefer R, Gold R, Hemmer B, Willison HJ, Hartung HP. Advances in understanding and treatment of immune-mediated disorders of the peripheral nervous system. Muscle Nerve 2004; 30: 131-156.
2. McGrogan A, Madle GC, Seaman HE, de Vries CS. The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology 2009; 32: 150-163. doi:10.1159/000184748.
3. Lehmann HC, Köhne A, Meyer zu Hörste G, Kieseier BC. Incidence of Guillain-Barré syndrome in Germany. J Peripher Nerv Syst 2007; 12: 285.
4. Yuki N, Hartung HP. Guillain-Barré syndrome. N Engl J Med 2012; 366: 2294-2304. doi:10.1056/NEJMra1114525.
5. Lehmann HC, Hartung HP, Kieseier BC, Hughes RA. Guillain-Barré syndrome after exposure to influenza virus. Lancet Infect Dis 2010; 10: 643-651. doi:10.1016/S1473-3099(10)70140-7.
6. Lehmann HC, Hughes RA, Kieseier BC, Hartung HP. Recent developments and future directions in Guillain-Barré syndrome. J Peripher Nerv Syst 2012; 17(suppl 3): 57-70. doi:10.1111/j.1529-8027.2012.00433.x.
7. Khandaker G, Zurynski Y, Buttery J, et al. Neurologic complications of influenza A(H1N1)pdm09: surveillance in 6 pediatric hospitals. Neurology 2012; 79: 1474-1481. doi:10.1212/WNL.0b013e31826d5ea7.
8. Chaari A, Bahloul M, Dammak H, et al. Guillain-Barré syndrome related to pandemic influenza A (H1N1) infection. Intensive Care Med 2010; 36: 1275. doi:10.1007/s00134-010-1895-4.
9. Kutlesa M, Santini M, Krajinovic V, Raffanelli D, Barsic B. Acute motor axonal neuropathy associated with pandemic H1N1 influenza A infection. Neurocrit Care 2010; 13: 98-100. doi:10.1007/s12028-010-9365-y.
10. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol 1979; 110: 105-123.
11. Safranek TJ, Lawrence DN, Kurland LT, et al. Reassessment of the association between Guillain-Barré syndrome and receipt of swine influenza vaccine in 1976-1977: results of a two-state study. Am J Epidemiol 1991; 133: 940-951.
12. Stratton K, Alamario DA, Wizemann T, McCormick MC (eds). Immunization Safety Review: Influenza Vaccines and Neurological Complications. The National Academies Press: Washington, DC, 2003, pp. 45-95. Available at: http://www.iom.edu/Reports/2003/Immunization-Safety-Review-Influenza-Vaccines-and-Neurological-Complications.aspx [16 September 2013].
13. Hughes RA, Charlton J, Latinovic R, Gulliford MC. No association between immunization and Guillain-Barré syndrome in the United Kingdom, 1992 to 2000. Arch Intern Med 2006; 166: 1301-1304.
14. Hurwitz ES, Schonberger LB, Nelson DB, Holman RC. Guillain-Barré syndrome and the 1978-1979 influenza vaccine. N Engl J Med 1981; 304: 1557-1561.
15. Kaplan JE, Katona P, Hurwitz ES, Schonberger LB. Guillain-Barré syndrome in the United States, 1979-1980 and 1980-1981. Lack of an association with influenza vaccination. JAMA 1982; 248: 698-700.
16. Roscelli JD, Bass JW, Pang L. Guillain-Barré syndrome and influenza vaccination in the US army, 1980-1988. Am J Epidemiol 1991; 133: 952-955.
17. Stowe J, Andrews N, Wise L, Miller E. Investigation of the temporal association of Guillain-Barré syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database. Am J Epidemiol 2009; 169: 382-388. doi:10.1093/aje/kwn310.
18. Juurlink DN, Stukel TA, Kwong J, et al. Guillain-Barré syndrome after influenza vaccination in adults: a population-based study. Arch Intern Med 2006; 166: 2217-2221.
19. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998; 339: 1797-1802.
20. Whitaker HJ, Farrington CP, Spiessens B, Musonda P. Tutorial in biostatistics: the self-controlled case series method. Stat Med 2006; 25: 1768-1797.
21. Farrington CP. Relative incidence estimation from case series for vaccine safety evaluation. Biometrics 1995; 51: 228-235.
22. Whitaker HJ, Hocine MN, Farrington CP. The methodology of self-controlled case series studies. Stat Methods Med Res 2009; 18: 7-26. doi:10.1177/0962280208092342.
23. Farrington CP, Whitaker HJ, Hocine MN. Case series analysis for censored, perturbed, or curtailed post-event exposures. Biostatistics 2009; 10: 3-16. doi:10.1093/biostatistics/kxn013.
24. Walter D, Böhmer MM, Heiden M, Reiter S, Krause G, Wichmann O. Monitoring pandemic influenza A(H1N1) vaccination coverage in Germany 2009/10-results from thirteen consecutive cross-sectional surveys. Vaccine 2011; 29: 4008-4012. doi:10.1016/j.vaccine.2011.03.069.
25. Sejvar JJ, Kohl KS, Gidudu J, et al. Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2011; 29: 599-612. doi:10.1016/j.vaccine.2010.06.003.
26. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Chapman & Hall/CRC: Boca Raton, FL, 2000.
27. Weldeselassie YG, Whitaker HJ, Farrington CP. Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice. Epidemiol Infect 2011; 139: 1805-1817. doi:10.1017/S0950268811001531.
28. Hua W, Sun G, Dodd CN, et al. A simulation study to compare three self-controlled case series approaches: correction for violation of assumption and evaluation of bias. Pharmacoepidemiol Drug Saf 2013; 22: 819-825. doi:10.1002/pds.3451.
29. Wichmann O, Stöcker P, Poggensee G, et al. Pandemic influenza A(H1N1) 2009 breakthrough infections and estimates of vaccine effectiveness in Germany 2009-2010. Euro Surveill 2010; 15: pii:19561.
30. German Federal Statistical Office [Statistisches Bundesamt]. Statistics about cases with ICD-diagnosis GBS/FS according to ICD-hospital databases in Germany, categorized by month of hospital admission ["DRG-Statistik"]. Personal communication on 30-Nov-2012.
31. Tokars JI, Lewis P, DeStefano F, et al. The risk of Guillain-Barré syndrome associated with influenza A (H1N1) 2009 monovalent vaccine and 2009-2010 seasonal influenza vaccines: results from self-controlled analyses. Pharmacoepidemiol Drug Saf 2012; 21: 546-552. doi:10.1002/pds.3220.
32. Wise ME, Viray M, Sejvar JJ, et al. Guillain-Barré syndrome during the 2009-2010 H1N1 influenza vaccination campaign: population-based surveillance among 45 million Americans. Am J Epidemiol 2012; 175: 1110-1119. doi:10.1093/aje/kws196.
33. Greene SK, Rett M, Weintraub ES, et al. Risk of confirmed Guillain-Barré syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010. Am J Epidemiol 2012; 175: 1100-1109. doi:10.1093/aje/kws195.
34. Yih WK, Lee GM, Lieu TA, et al. Surveillance for adverse events following receipt of pandemic 2009 H1N1 vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System, 2009-2010. Am J Epidemiol 2012; 175: 1120-1128. doi:10.1093/aje/kws197.
35. Polakowski LL, Sandhu SK, Martin DB, et al. Chart-confirmed Guillain-Barré syndrome after 2009 H1N1 influenza vaccination among the Medicare population. Am J Epidemiol 2013; 178: 962-973. doi:10.1093/aje/kwt051.
36. Salmon DA, Proschan M, Forshee R, et al. Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet 2013; 381: 1461-1468. doi:10.1016/S0140-6736(12)62189-8.
37. De Wals P, Deceuninck G, Toth E, et al. Risk of Guillain-Barré syndrome following H1N1 influenza vaccination in Quebec. JAMA 2012; 308: 175-181. doi:10.1001/jama.2012.7342.
38. Dodd CN, Romio SA, Black S, et al. International collaboration to assess the risk of Guillain Barré syndrome following influenza A(H1N1) 2009 monovalent vaccines. Vaccine 2013; 31: 4448-4458. doi:10.1016/j.vaccine.2013.06.032.
39. Andrews N, Stowe J, Al-Shahi Salman R, Miller E. Guillain-Barré syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: self-controlled case series. Vaccine 2011; 29: 7878-7882. doi:10.1016/j.vaccine.2011.08.069.
40. Dieleman J, Romio S, Johansen K, et al. Guillain-Barré syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 2011; 343: d3908. DOI: 10.1136/bmj.d3908
41. Romio S, Weibel D, Dieleman JP, et al. Guillain-Barré syndrome and adjuvanted pandemic influenza A(H1N1) 2009 vaccines: a multinational self-controlled case series in Europe. PLoS One 2014; 9: e82222. DOI: 10.1371/journal.pone.0082222
42. Bardage C, Persson I, Örtqvist 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; 343: d5956. DOI: 10.1136/bmj.d5956
43. Grimaldi-Bensouda L, Alpérovitch A, Besson G, et al. Guillain-Barré syndrome, influenzalike illnesses, and influenza vaccination during seasons with and without circulating A/H1N1 viruses. Am J Epidemiol 2011; 174: 326-335. doi:10.1093/aje/kwr072.
44. Crawford NW, Cheng A, Andrews N, et al. Guillain-Barré syndrome following pandemic (H1N1) 2009 influenza A immunisation in Victoria: a self-controlled case series. Med J Aust 2012; 197: 574-578. doi:10.5694/mja12.10534.