Universität zu Köln

Prestel, Juergen, Volkers, Peter, Mentzer, Dirk, Lehmann, Helmar C., Hartung, Hans-Peter and Keller-Stanislawski, Brigitte (2014). Risk of Guillain-Barre syndrome following pandemic influenza A (H1N1) 2009 vaccination in Germany. Pharmacoepidemiol. Drug Saf., 23 (11). S. 1192 - 1205. HOBOKEN: WILEY-BLACKWELL. ISSN 1099-1557

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Abstract

PurposeA prospective, epidemiologic study was conducted to assess whether the 2009 pandemic influenza A(H1N1) vaccination in Germany almost exclusively using an AS03-adjuvanted vaccine (Pandemrix) impacts the risk of Guillain-Barre syndrome (GBS) and its variant Fisher syndrome (FS). MethodsPotential cases of GBS/FS were reported by 351 participating hospitals throughout Germany. The self-controlled case series methodology was applied to all GBS/FS cases fulfilling the Brighton Collaboration (BC) case definition (levels 1-3 of diagnostic certainty) with symptom onset between 1 November 2009 and 30 September 2010 reported until end of December 2010. ResultsOut of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1-3) occurred within 150days following influenza A(H1N1) vaccination. The relative incidence of GBS/FS within the primary risk period (days 5-42 post-vaccination) compared with the control period (days 43-150 post-vaccination) was 4.65 (95%CI [2.17, 9.98]). Similar results were found when stratifying for infections within 3weeks prior to onset of GBS/FS and when excluding cases with additional seasonal influenza vaccination. The overall result of temporally adjusted analyses supported the primary finding of an increased relative incidence of GBS/FS following influenza A(H1N1) vaccination. ConclusionsThe results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany. (c) 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Prestel, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Volkers, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Mentzer, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmann, Helmar C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hartung, Hans-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Keller-Stanislawski, Brigitte UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-424313
DOI:	10.1002/pds.3638
Journal or Publication Title:	Pharmacoepidemiol. Drug Saf.
Volume:	23
Number:	11
Page Range:	S. 1192 - 1205
Date:	2014
Publisher:	WILEY-BLACKWELL
Place of Publication:	HOBOKEN
ISSN:	1099-1557
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CONTROLLED CASE-SERIES; UNITED-KINGDOM; IMMUNIZATION; ASSOCIATION; VACCINES; SAFETY; SURVEILLANCE; POPULATION; RECEIPT; SYSTEM Multiple languages Public, Environmental & Occupational Health; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42431