Risk of Guillain-Barré syndrome following pandemic influenza A (H1N1) 2009 vaccination in Germany
Identifieur interne : 001026 ( Main/Exploration ); précédent : 001025; suivant : 001027Risk of Guillain-Barré syndrome following pandemic influenza A (H1N1) 2009 vaccination in Germany
Auteurs : Jürgen Prestel [Allemagne] ; Peter Volkers [Allemagne] ; Dirk Mentzer [Allemagne] ; Helmar C. Lehmann [Allemagne] ; Hans-Peter Hartung [Allemagne] ; Brigitte Keller-Stanislawski [Allemagne]Source :
- Pharmacoepidemiology and drug safety [ 1053-8569 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : Allemagne.
- topic : Vaccination, Médicament.
English descriptors
- KwdEn :
Abstract
Purpose A 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-Barré syndrome (GBS) and its variant Fisher syndrome (FS). Methods Potential 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. Results Out of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1-3) occurred within 150 days 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 3 weeks 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. Conclusions The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany.
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Lehmann</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Neurology, Heinrich-Heine-University Düsseldorf</s1><s2>Düsseldorf</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Düsseldorf</region><settlement type="city">Düsseldorf</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Neurology, University Hospital of Cologne</s1><s2>Cologne</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Cologne</wicri:noRegion><wicri:noRegion>University Hospital of Cologne</wicri:noRegion><wicri:noRegion>Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Hartung, Hans Peter" sort="Hartung, Hans Peter" uniqKey="Hartung H" first="Hans-Peter" last="Hartung">Hans-Peter Hartung</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Neurology, Heinrich-Heine-University Düsseldorf</s1><s2>Düsseldorf</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Düsseldorf</region><settlement type="city">Düsseldorf</settlement></placeName></affiliation></author><author><name sortKey="Keller Stanislawski, Brigitte" sort="Keller Stanislawski, Brigitte" uniqKey="Keller Stanislawski B" first="Brigitte" last="Keller-Stanislawski">Brigitte Keller-Stanislawski</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines</s1><s2>Langen</s2><s3>DEU</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Federal Institute for Vaccines and Biomedicines</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Pharmacoepidemiology and drug safety</title><title level="j" type="abbreviated">Pharmacoepidemiol. drug saf.</title><idno type="ISSN">1053-8569</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Pharmacoepidemiology and drug safety</title><title level="j" type="abbreviated">Pharmacoepidemiol. drug saf.</title><idno type="ISSN">1053-8569</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Drug</term><term>Epidemiology</term><term>Germany</term><term>Guillain-Barré syndrome</term><term>H1N1 influenza</term><term>Influenza A</term><term>Pharmacovigilance</term><term>Prevention</term><term>Risk factor</term><term>Treatment efficiency</term><term>Vaccination</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Facteur risque</term><term>Polyradiculonévrite de Guillain-Barré</term><term>Grippe A</term><term>Vaccination</term><term>Prévention</term><term>Allemagne</term><term>Epidémiologie</term><term>Médicament</term><term>Pharmacovigilance</term><term>Efficacité traitement</term><term>Grippe pandémique</term><term>Pharmacoépidémiologie</term><term>Grippe H1N1</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Allemagne</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccination</term><term>Médicament</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose A 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-Barré syndrome (GBS) and its variant Fisher syndrome (FS). Methods Potential 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. Results Out of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1-3) occurred within 150 days 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 3 weeks 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. Conclusions The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>District de Düsseldorf</li><li>Rhénanie-du-Nord-Westphalie</li></region><settlement><li>Düsseldorf</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Prestel, Jurgen" sort="Prestel, Jurgen" uniqKey="Prestel J" first="Jürgen" last="Prestel">Jürgen Prestel</name></noRegion><name sortKey="Hartung, Hans Peter" sort="Hartung, Hans Peter" uniqKey="Hartung H" first="Hans-Peter" last="Hartung">Hans-Peter Hartung</name><name sortKey="Keller Stanislawski, Brigitte" sort="Keller Stanislawski, Brigitte" uniqKey="Keller Stanislawski B" first="Brigitte" last="Keller-Stanislawski">Brigitte Keller-Stanislawski</name><name sortKey="Lehmann, Helmar C" sort="Lehmann, Helmar C" uniqKey="Lehmann H" first="Helmar C." last="Lehmann">Helmar C. Lehmann</name><name sortKey="Lehmann, Helmar C" sort="Lehmann, Helmar C" uniqKey="Lehmann H" first="Helmar C." last="Lehmann">Helmar C. Lehmann</name><name sortKey="Mentzer, Dirk" sort="Mentzer, Dirk" uniqKey="Mentzer D" first="Dirk" last="Mentzer">Dirk Mentzer</name><name sortKey="Volkers, Peter" sort="Volkers, Peter" uniqKey="Volkers P" first="Peter" last="Volkers">Peter Volkers</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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