Guillain-Barré syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: A multinational self-controlled case series in Europe

PLoS ONE

Volumn 9, Issue 1, 2014, Pages

  Romio, Silvana ^a   Weibel, Daniel ^a,o   Dieleman, Jeanne P ^a   Olberg, Henning K ^b   De Vries, Corinne S ^c   Sammon, Cormac ^c   Andrews, Nick ^d   Svanström, Henrik ^e   Mølgaard Nielsen, Ditte ^e   Hviid, Anders ^e   Lapeyre Mestre, Maryse ^f   Sommet, Agnès ^f   Saussier, Christel ^g   Castot, Anne ^h   Heijbel, Harald ⁱ   Arnheim Dahlström, Lisen ^j   Sparen, Par ^j   Mosseveld, Mees ^a   Schuemie, Martijn ^a   Van Der Maas, Nicoline ^k   Jacobs, Bart C ^a   Leino, Tuija ^l   Kilpi, Terhi ^l   Storsaeter, Jann ^m   Johansen, Kari ⁿ   Kramarz, Piotr ⁿ   Bonhoeffer, Jan ^o,p   Sturkenboom, Miriam C J M ^a   more..

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^c University of Bath   (United Kingdom)

^d PUBLIC HEALTH ENGLAND   (United Kingdom)

^e STATENS SERUM INSTITUT   (Denmark)

^f TOULOUSE UNIVERSITY HOSPITAL   (France)

^g Department of Epidemiology of Health Products   (France)

^h Swedish Institute for Infectious Disease Control ^*

ⁱ SWEDISH INSTITUTE FOR INFECTIOUS DISEASE CONTROL   (Sweden)

^j KAROLINSKA INSTITUTE   (Sweden)

^k NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^l NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^m NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

ⁿ EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL ECDC   (Sweden)

^o Brighton Collaboration Foundation   (Switzerland)

^p UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE;

ADULT; ARTICLE; CASE STUDY; CHILD; DENMARK; DRUG CONTRAINDICATION; DRUG SAFETY; FEMALE; FINLAND; GUILLAIN BARRE SYNDROME; HUMAN; INFLUENZA VACCINATION; MAJOR CLINICAL STUDY; MALE; NETHERLANDS; NORWAY; PANDEMIC INFLUENZA; POISSON DISTRIBUTION; RISK ASSESSMENT; SWEDEN; UNITED KINGDOM;

ADOLESCENT; ADULT; AGED; CHILD; CHILD, PRESCHOOL; EUROPE; FEMALE; FOLLOW-UP STUDIES; GUILLAIN-BARRE SYNDROME; HUMANS; INCIDENCE; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; ODDS RATIO; POPULATION SURVEILLANCE; YOUNG ADULT;

EID: 84896780343     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0082222     Document Type: Article

References (28)

1. Lu CY, Shao PL, Chang LY, Huang YC, Chiu CH, et al. (2010) Immunogenicity and safety of a monovalent vaccine for the 2009 pandemic influenza virus A (H1N1) in children and adolescents. Vaccine 28: 5864-5870.
2. Lu W, Tambyah PA (2010) Safety and immunogenicity of influenza A H1N1 vaccines. Expert Rev Vaccines 9: 365-369.
3. Wijnans L, de Bie S, Dieleman J, Bonhoeffer J, Sturkenboom M (2011) Safety of pandemic H1N1 vaccines in children and adolescents. Vaccine 29: 7559-7571.
4. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, et al. (1979) Guillain-Barrésyndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol 110: 105-123. (Pubitemid 10209694)
5. Hurwitz ES, Schonberger LB, Nelson DB, Holman RC (1981) Guillain-Barrésyndrome and the 1978-1979 influenza vaccine. N Engl J Med 304: 1557-1561.
6. Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, et al. (2006) Guillain-Barrésyndrome after influenza vaccination in adults: a population-based study. Arch Intern Med 166: 2217-2221. (Pubitemid 44748768)
7. Kaplan JE, Katona P, Hurwitz ES, Schonberger LB (1982) Guillain-Barrésyndrome in the United States, 1979-1980 and 1980-1981. Lack of an association with influenza vaccination. JAMA 248: 698-700. (Pubitemid 12097759)
8. Lasky T, Terracciano GJ, Magder L, Koski CL, Ballesteros M, et al. (1998) The Guillain-Barrésyndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 339: 1797-1802. (Pubitemid 29005783)
9. Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, et al. (2011) Guillain-Barrésyndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 29: 599-612.
10. van Doorn PA, Ruts L, Jacobs BC (2008) Clinical features, pathogenesis, and treatment of Guillain-Barrésyndrome. Lancet Neurol 7: 939-950.
11. McGrogan A, Madle GC, Seaman HE, de Vries CS (2009) The epidemiology of Guillain-Barrésyndrome worldwide. A systematic literature review. Neuroepidemiology 32: 150-163.
12. Govoni V, Granieri E (2001) Epidemiology of the Guillain- Barrésyndrome. Curr Opin Neurol 14: 605-613.
13. Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, et al. (2011) Guillain-Barrésyndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 343: d3908.
14. Farrington CP, Whitaker HJ, Hocine MN (2009) Case series analysis for censored, perturbed, or curtailed post-event exposures. Biostatistics 10: 3-16. (Pubitemid 352847902)
15. Coloma PM, Schuemie MJ, Trifiro G, Gini R, Herings R, et al. (2011) Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 20: 1-11.
16. Grimaldi-Bensouda L, Alperovitch A, Besson G, Vial C, Cuisset JM, et al. (2011) Guillain-Barrésyndrome, influenzalike illnesses, and influenza vaccination during seasons with and without circulating A/H1N1 viruses. Am J Epidemiol 174: 326-335.
17. Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, et al. (2011) Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ 343: d5956.
18. Andrews N, Stowe J, Al-Shahi Salman R, Miller E (2011) Guillain-Barrésyndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: self-controlled case series. Vaccine 29: 7878-7882.
19. Paul-Ehrlich-Institut (2012) Zusammenhang zwischen pandemischer Influenza A/H1N1v-Impfung und Guillain-Barré syndrome/Miller-Fisher syndrome in Deutschland.
20. Wise ME, Viray M, Sejvar JJ, Lewis P, Baughman AL, et al. (2012) Guillain-Barré Syndrome During the 2009-2010 H1N1 Influenza Vaccination Campaign: Population-based Surveillance Among 45 Million Americans. Am J Epidemiol 175: 1110-1119.
21. Tokars JI, Lewis P, DeStefano F, Wise M, Viray M, et al. (2012) 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 21: 546-552.
22. Yih WK, Lee GM, Lieu TA, Ball R, Kulldorff M, et al. (2012) 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 175: 1120-1128.
23. Greene SK, Rett M, Weintraub ES, Li L, Yin R, et al. (2012) 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 175: 1100-1109.
24. Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, et al. (2013) Association between Guillain-Barre syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet.
25. De Wals P, Deceuninck G, Toth E, Boulianne N, Brunet D, et al. (2012) Risk of Guillain-Barré syndrome following H1N1 influenza vaccination in Quebec. JAMA 308: 175-181.
26. Greene SK, Rett MD, Vellozzi C, Li L, Kulldorff M, et al. (2013) Guillain-Barre Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011. PLoS One 8: e67185.
27. Poland GA, Poland CM, Howe CL (2013) Influenza vaccine and Guillain-Barre syndrome: making informed decisions. Lancet 381: 1437-1439.
28. Stowe J, Andrews N, Wise L, Miller E (2009) Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database. Am J Epidemiol 169: 382-388.