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

Identifieur interne : 000033 ( PascalFrancis/Checkpoint ); précédent : 000032; suivant : 000034

Risk 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]

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RBID : Pascal:14-0279354

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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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<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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<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Allemagne</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Germany</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Alemania</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Epidémiologie</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Epidemiology</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Epidemiología</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Médicament</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Drug</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Medicamento</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Pharmacovigilance</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Pharmacovigilance</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Farmacovigilancia</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Efficacité traitement</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Treatment efficiency</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Eficacia tratamiento</s0>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Grippe pandémique</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Pharmacoépidémiologie</s0>
<s4>INC</s4>
<s5>87</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Grippe H1N1</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>H1N1 influenza</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Gripe H1N1</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Virose</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Viral disease</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Virosis</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Infección</s0>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Europa</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Maladie inflammatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Inflammatory disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Enfermedad inflamatoria</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Pathologie du système nerveux périphérique</s0>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Peripheral nerve disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Nervio periférico patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Pathologie du système nerveux</s0>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Pathologie de l'appareil respiratoire</s0>
<s5>40</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Respiratory disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Aparato respiratorio patología</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>349</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<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>

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