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

Identifieur interne : 000019 ( PascalFrancis/Corpus ); précédent : 000018; suivant : 000020

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

Auteurs : Jürgen Prestel ; Peter Volkers ; Dirk Mentzer ; Helmar C. Lehmann ; Hans-Peter Hartung ; Brigitte Keller-Stanislawski

Source :

RBID : Pascal:14-0279354

Descripteurs français

English descriptors

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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Pour connaître la documentation sur le format Inist Standard.

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A11 01  1    @1 PRESTEL (Jürgen)
A11 02  1    @1 VOLKERS (Peter)
A11 03  1    @1 MENTZER (Dirk)
A11 04  1    @1 LEHMANN (Helmar C.)
A11 05  1    @1 HARTUNG (Hans-Peter)
A11 06  1    @1 KELLER-STANISLAWSKI (Brigitte)
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C01 01    ENG  @0 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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Format Inist (serveur)

NO : PASCAL 14-0279354 INIST
ET : Risk of Guillain-Barré syndrome following pandemic influenza A (H1N1) 2009 vaccination in Germany
AU : PRESTEL (Jürgen); VOLKERS (Peter); MENTZER (Dirk); LEHMANN (Helmar C.); HARTUNG (Hans-Peter); KELLER-STANISLAWSKI (Brigitte)
AF : Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines/Langen/Allemagne (1 aut., 3 aut., 6 aut.); Division of EU Co-operation/Microbiology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines/Langen/Allemagne (2 aut.); Department of Neurology, Heinrich-Heine-University Düsseldorf/Düsseldorf/Allemagne (4 aut., 5 aut.); Department of Neurology, University Hospital of Cologne/Cologne/Allemagne (4 aut.)
DT : Publication en série; Niveau analytique
SO : Pharmacoepidemiology and drug safety; ISSN 1053-8569; Coden PDSAEA; Royaume-Uni; Da. 2014; Vol. 23; No. 11; Pp. 1192-1204; Bibl. 44 ref.
LA : Anglais
EA : 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.
CC : 002B02A06; 002B17F; 002B05C02C
FD : Facteur risque; Polyradiculonévrite de Guillain-Barré; Grippe A; Vaccination; Prévention; Allemagne; Epidémiologie; Médicament; Pharmacovigilance; Efficacité traitement; Grippe pandémique; Pharmacoépidémiologie; Grippe H1N1
FG : Virose; Infection; Europe; Maladie inflammatoire; Pathologie du système nerveux périphérique; Pathologie du système nerveux; Pathologie de l'appareil respiratoire
ED : Risk factor; Guillain-Barré syndrome; Influenza A; Vaccination; Prevention; Germany; Epidemiology; Drug; Pharmacovigilance; Treatment efficiency; H1N1 influenza
EG : Viral disease; Infection; Europe; Inflammatory disease; Peripheral nerve disease; Nervous system diseases; Respiratory disease
SD : Factor riesgo; Polirradiculoneuritis Guillain-Barré; Gripe A; Vacunación; Prevención; Alemania; Epidemiología; Medicamento; Farmacovigilancia; Eficacia tratamiento; Gripe H1N1
LO : INIST-27568.354000502503730110
ID : 14-0279354

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Le document en format XML

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<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>
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<s1>Department of Neurology, Heinrich-Heine-University Düsseldorf</s1>
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<sZ>5 aut.</sZ>
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<server>
<NO>PASCAL 14-0279354 INIST</NO>
<ET>Risk of Guillain-Barré syndrome following pandemic influenza A (H1N1) 2009 vaccination in Germany</ET>
<AU>PRESTEL (Jürgen); VOLKERS (Peter); MENTZER (Dirk); LEHMANN (Helmar C.); HARTUNG (Hans-Peter); KELLER-STANISLAWSKI (Brigitte)</AU>
<AF>Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines/Langen/Allemagne (1 aut., 3 aut., 6 aut.); Division of EU Co-operation/Microbiology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines/Langen/Allemagne (2 aut.); Department of Neurology, Heinrich-Heine-University Düsseldorf/Düsseldorf/Allemagne (4 aut., 5 aut.); Department of Neurology, University Hospital of Cologne/Cologne/Allemagne (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Pharmacoepidemiology and drug safety; ISSN 1053-8569; Coden PDSAEA; Royaume-Uni; Da. 2014; Vol. 23; No. 11; Pp. 1192-1204; Bibl. 44 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B02A06; 002B17F; 002B05C02C</CC>
<FD>Facteur risque; Polyradiculonévrite de Guillain-Barré; Grippe A; Vaccination; Prévention; Allemagne; Epidémiologie; Médicament; Pharmacovigilance; Efficacité traitement; Grippe pandémique; Pharmacoépidémiologie; Grippe H1N1</FD>
<FG>Virose; Infection; Europe; Maladie inflammatoire; Pathologie du système nerveux périphérique; Pathologie du système nerveux; Pathologie de l'appareil respiratoire</FG>
<ED>Risk factor; Guillain-Barré syndrome; Influenza A; Vaccination; Prevention; Germany; Epidemiology; Drug; Pharmacovigilance; Treatment efficiency; H1N1 influenza</ED>
<EG>Viral disease; Infection; Europe; Inflammatory disease; Peripheral nerve disease; Nervous system diseases; Respiratory disease</EG>
<SD>Factor riesgo; Polirradiculoneuritis Guillain-Barré; Gripe A; Vacunación; Prevención; Alemania; Epidemiología; Medicamento; Farmacovigilancia; Eficacia tratamiento; Gripe H1N1</SD>
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<ID>14-0279354</ID>
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