PandemieGrippaleV1, France, Analysis, bibRecord, 000537

Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France

Identifieur interne : 000537 ( France/Analysis ); précédent : 000536; suivant : 000538

Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France

Auteurs : Yves Dauvilliers [France] ; Isabelle Arnulf [France] ; Michel Lecendreux [France] ; Christelle Monaca Charley [France] ; Patricia Franco [France] ; Xavier Drouot [France] ; Marie-Pia D'Ortho [France] ; Sandrine Launois [France] ; Séverine Lignot [France] ; Patrice Bourgin [France] ; Béatrice Nogues [France] ; Marc Rey [France] ; Sophie Bayard [France] ; Sabine Scholz [France] ; Sophie Lavault [France] ; Pascale Tubert-Bitter [France] ; Cristel Saussier [France] ; Antoine Pariente [France]

Source :

Brain [ 0006-8950 ] ; 2013.

RBID : Pascal:13-0247443

Descripteurs français

Pascal (Inist)
- Narcolepsie, Infection, Pathologie du système nerveux, Facteur risque, Enfant, Vaccination, France, Cataplexie, Prévention, Vaccin, Grippe H1N1.
Wicri :
- geographic : France.
- topic : Enfant, Vaccination, Vaccin.

English descriptors

KwdEn :
- Cataplexy, Child, France, H1N1 influenza, Infection, Narcolepsy, Nervous system diseases, Prevention, Risk factor, Vaccination, Vaccine.

Abstract

An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.

Affiliations:

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Pascal:13-0247443

Le document en format XML

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<author><name sortKey="Monaca Charley, Christelle" sort="Monaca Charley, Christelle" uniqKey="Monaca Charley C" first="Christelle" last="Monaca Charley">Christelle Monaca Charley</name>
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<author><name sortKey="D Ortho, Marie Pia" sort="D Ortho, Marie Pia" uniqKey="D Ortho M" first="Marie-Pia" last="D'Ortho">Marie-Pia D'Ortho</name>
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<author><name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
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<author><name sortKey="Lignot, Severine" sort="Lignot, Severine" uniqKey="Lignot S" first="Séverine" last="Lignot">Séverine Lignot</name>
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<author><name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
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<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
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</affiliation>
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<author><name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
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</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
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<region type="old region">Île-de-France</region>
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<author><name sortKey="Tubert Bitter, Pascale" sort="Tubert Bitter, Pascale" uniqKey="Tubert Bitter P" first="Pascale" last="Tubert-Bitter">Pascale Tubert-Bitter</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>16 aut.</sZ>
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<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>UMRS 1018</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
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</author>
<author><name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Agence Nationale de Sécurité des Medicaments et des Produits de Santé</s1>
<s2>Saint-Denis</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Saint-Denis (Seine-Saint-Denis)</settlement>
</placeName>
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<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
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<country>France</country>
<wicri:noRegion>CHU de Bordeaux</wicri:noRegion>
<wicri:noRegion>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</wicri:noRegion>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France</title>
<author><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
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<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lecendreux, Michel" sort="Lecendreux, Michel" uniqKey="Lecendreux M" first="Michel" last="Lecendreux">Michel Lecendreux</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Monaca Charley, Christelle" sort="Monaca Charley, Christelle" uniqKey="Monaca Charley C" first="Christelle" last="Monaca Charley">Christelle Monaca Charley</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital</s1>
<s2>Lille</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Franco, Patricia" sort="Franco, Patricia" uniqKey="Franco P" first="Patricia" last="Franco">Patricia Franco</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Drouot, Xavier" sort="Drouot, Xavier" uniqKey="Drouot X" first="Xavier" last="Drouot">Xavier Drouot</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="D Ortho, Marie Pia" sort="D Ortho, Marie Pia" uniqKey="D Ortho M" first="Marie-Pia" last="D'Ortho">Marie-Pia D'Ortho</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris</s1>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Université Denis Diderot Paris 7Paris</wicri:noRegion>
<wicri:noRegion>Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042</s1>
<s2>Grenoble</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Grenoble</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lignot, Severine" sort="Lignot, Severine" uniqKey="Lignot S" first="Séverine" last="Lignot">Séverine Lignot</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>CHU de Bordeaux</wicri:noRegion>
<wicri:noRegion>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bourgin, Patrice" sort="Bourgin, Patrice" uniqKey="Bourgin P" first="Patrice" last="Bourgin">Patrice Bourgin</name>
<affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212</s1>
<s2>Strasbourg</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Grand Est</region>
<region type="old region">Alsace (région administrative)</region>
<settlement type="city">Strasbourg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nogues, Beatrice" sort="Nogues, Beatrice" uniqKey="Nogues B" first="Béatrice" last="Nogues">Béatrice Nogues</name>
<affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Clinical Neurophysiology Unit, La Timone Hospital</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
<wicri:noRegion>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tubert Bitter, Pascale" sort="Tubert Bitter, Pascale" uniqKey="Tubert Bitter P" first="Pascale" last="Tubert-Bitter">Pascale Tubert-Bitter</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>UMRS 1018</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Agence Nationale de Sécurité des Medicaments et des Produits de Santé</s1>
<s2>Saint-Denis</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Saint-Denis (Seine-Saint-Denis)</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>CHU de Bordeaux</wicri:noRegion>
<wicri:noRegion>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cataplexy</term>
<term>Child</term>
<term>France</term>
<term>H1N1 influenza</term>
<term>Infection</term>
<term>Narcolepsy</term>
<term>Nervous system diseases</term>
<term>Prevention</term>
<term>Risk factor</term>
<term>Vaccination</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Narcolepsie</term>
<term>Infection</term>
<term>Pathologie du   système nerveux</term>
<term>Facteur risque</term>
<term>Enfant</term>
<term>Vaccination</term>
<term>France</term>
<term>Cataplexie</term>
<term>Prévention</term>
<term>Vaccin</term>
<term>Grippe H1N1</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Enfant</term>
<term>Vaccination</term>
<term>Vaccin</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.</div>
</front>
</TEI>
<affiliations><list><country><li>France</li>
</country>
<region><li>Alsace (région administrative)</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Grand Est</li>
<li>Hauts-de-France</li>
<li>Languedoc-Roussillon</li>
<li>Nord-Pas-de-Calais</li>
<li>Occitanie (région administrative)</li>
<li>Pays de la Loire</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhône-Alpes</li>
<li>Île-de-France</li>
</region>
<settlement><li>Créteil</li>
<li>Grenoble</li>
<li>Lille</li>
<li>Lyon</li>
<li>Marseille</li>
<li>Montpellier</li>
<li>Nantes</li>
<li>Paris</li>
<li>Saint-Denis (Seine-Saint-Denis)</li>
<li>Strasbourg</li>
</settlement>
</list>
<tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name>
</region>
<name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name>
<name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name>
<name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<name sortKey="Bourgin, Patrice" sort="Bourgin, Patrice" uniqKey="Bourgin P" first="Patrice" last="Bourgin">Patrice Bourgin</name>
<name sortKey="D Ortho, Marie Pia" sort="D Ortho, Marie Pia" uniqKey="D Ortho M" first="Marie-Pia" last="D'Ortho">Marie-Pia D'Ortho</name>
<name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name>
<name sortKey="Drouot, Xavier" sort="Drouot, Xavier" uniqKey="Drouot X" first="Xavier" last="Drouot">Xavier Drouot</name>
<name sortKey="Franco, Patricia" sort="Franco, Patricia" uniqKey="Franco P" first="Patricia" last="Franco">Patricia Franco</name>
<name sortKey="Franco, Patricia" sort="Franco, Patricia" uniqKey="Franco P" first="Patricia" last="Franco">Patricia Franco</name>
<name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
<name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
<name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
<name sortKey="Lecendreux, Michel" sort="Lecendreux, Michel" uniqKey="Lecendreux M" first="Michel" last="Lecendreux">Michel Lecendreux</name>
<name sortKey="Lecendreux, Michel" sort="Lecendreux, Michel" uniqKey="Lecendreux M" first="Michel" last="Lecendreux">Michel Lecendreux</name>
<name sortKey="Lignot, Severine" sort="Lignot, Severine" uniqKey="Lignot S" first="Séverine" last="Lignot">Séverine Lignot</name>
<name sortKey="Monaca Charley, Christelle" sort="Monaca Charley, Christelle" uniqKey="Monaca Charley C" first="Christelle" last="Monaca Charley">Christelle Monaca Charley</name>
<name sortKey="Nogues, Beatrice" sort="Nogues, Beatrice" uniqKey="Nogues B" first="Béatrice" last="Nogues">Béatrice Nogues</name>
<name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<name sortKey="Tubert Bitter, Pascale" sort="Tubert Bitter, Pascale" uniqKey="Tubert Bitter P" first="Pascale" last="Tubert-Bitter">Pascale Tubert-Bitter</name>
</country>
</tree>
</affiliations>
</record>

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{{Explor lien
   |wiki=    Sante
   |area=    PandemieGrippaleV1
   |flux=    France
   |étape=   Analysis
   |type=    RBID
   |clé=     Pascal:13-0247443
   |texte=   Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France
}}

This area was generated with Dilib version V0.6.34.
Data generation: Wed Jun 10 11:04:28 2020. Site generation: Sun Mar 28 09:10:28 2021

	Serveur d'exploration sur les pandémies grippales
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Serveur d'exploration sur les pandémies grippales

Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France

Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France

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