Serveur d'exploration sur les pandémies grippales

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

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

Identifieur interne : 001B74 ( PascalFrancis/Curation ); précédent : 001B73; suivant : 001B75

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 :

RBID : Pascal:13-0247443

Descripteurs français

English descriptors

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.
pA  
A01 01  1    @0 0006-8950
A03   1    @0 Brain
A05       @2 136
A06       @3 p. 8
A08 01  1  ENG  @1 Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France
A11 01  1    @1 DAUVILLIERS (Yves)
A11 02  1    @1 ARNULF (Isabelle)
A11 03  1    @1 LECENDREUX (Michel)
A11 04  1    @1 MONACA CHARLEY (Christelle)
A11 05  1    @1 FRANCO (Patricia)
A11 06  1    @1 DROUOT (Xavier)
A11 07  1    @1 D'ORTHO (Marie-Pia)
A11 08  1    @1 LAUNOIS (Sandrine)
A11 09  1    @1 LIGNOT (Séverine)
A11 10  1    @1 BOURGIN (Patrice)
A11 11  1    @1 NOGUES (Béatrice)
A11 12  1    @1 REY (Marc)
A11 13  1    @1 BAYARD (Sophie)
A11 14  1    @1 SCHOLZ (Sabine)
A11 15  1    @1 LAVAULT (Sophie)
A11 16  1    @1 TUBERT-BITTER (Pascale)
A11 17  1    @1 SAUSSIER (Cristel)
A11 18  1    @1 PARIENTE (Antoine)
A14 01      @1 Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061 @2 Montpellier @3 FRA @Z 1 aut. @Z 13 aut. @Z 14 aut.
A14 02      @1 National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome) @3 FRA @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 5 aut. @Z 13 aut. @Z 14 aut. @Z 15 aut.
A14 03      @1 Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP @2 Paris @3 FRA @Z 2 aut. @Z 15 aut.
A14 04      @1 Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP @2 Paris @3 FRA @Z 3 aut.
A14 05      @1 Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital @2 Lille @3 FRA @Z 4 aut.
A14 06      @1 INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant @2 Lyon @3 FRA @Z 5 aut.
A14 07      @1 Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor @2 Creteil @3 FRA @Z 6 aut.
A14 08      @1 Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris @3 FRA @Z 7 aut.
A14 09      @1 Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042 @2 Grenoble @3 FRA @Z 8 aut.
A14 10      @1 Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux @3 FRA @Z 9 aut. @Z 18 aut.
A14 11      @1 Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212 @2 Strasbourg @3 FRA @Z 10 aut.
A14 12      @1 Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec @2 Nantes @3 FRA @Z 11 aut.
A14 13      @1 Clinical Neurophysiology Unit, La Timone Hospital @2 Marseille @3 FRA @Z 12 aut.
A14 14      @1 INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018 @2 Villejuif @3 FRA @Z 16 aut.
A14 15      @1 Agence Nationale de Sécurité des Medicaments et des Produits de Santé @2 Saint-Denis @3 FRA @Z 17 aut.
A17 01  1    @1 Narcoflu-VF study group @3 INC
A20       @1 2486-2496
A21       @1 2013
A23 01      @0 ENG
A43 01      @1 INIST @2 998 @5 354000506516950140
A44       @0 0000 @1 © 2013 INIST-CNRS. All rights reserved.
A45       @0 3/4 p.
A47 01  1    @0 13-0247443
A60       @1 P
A61       @0 A
A64 01  1    @0 Brain
A66 01      @0 GBR
C01 01    ENG  @0 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.
C02 01  X    @0 002B17
C02 02  X    @0 002B17G
C03 01  X  FRE  @0 Narcolepsie @5 01
C03 01  X  ENG  @0 Narcolepsy @5 01
C03 01  X  SPA  @0 Narcolepsia @5 01
C03 02  X  FRE  @0 Infection @5 02
C03 02  X  ENG  @0 Infection @5 02
C03 02  X  SPA  @0 Infección @5 02
C03 03  X  FRE  @0 Pathologie du système nerveux @5 03
C03 03  X  ENG  @0 Nervous system diseases @5 03
C03 03  X  SPA  @0 Sistema nervioso patología @5 03
C03 04  X  FRE  @0 Facteur risque @5 09
C03 04  X  ENG  @0 Risk factor @5 09
C03 04  X  SPA  @0 Factor riesgo @5 09
C03 05  X  FRE  @0 Enfant @5 10
C03 05  X  ENG  @0 Child @5 10
C03 05  X  SPA  @0 Niño @5 10
C03 06  X  FRE  @0 Vaccination @5 11
C03 06  X  ENG  @0 Vaccination @5 11
C03 06  X  SPA  @0 Vacunación @5 11
C03 07  X  FRE  @0 France @2 NG @5 12
C03 07  X  ENG  @0 France @2 NG @5 12
C03 07  X  SPA  @0 Francia @2 NG @5 12
C03 08  X  FRE  @0 Cataplexie @5 13
C03 08  X  ENG  @0 Cataplexy @5 13
C03 08  X  SPA  @0 Cataplexia @5 13
C03 09  X  FRE  @0 Prévention @5 14
C03 09  X  ENG  @0 Prevention @5 14
C03 09  X  SPA  @0 Prevención @5 14
C03 10  X  FRE  @0 Vaccin @5 15
C03 10  X  ENG  @0 Vaccine @5 15
C03 10  X  SPA  @0 Vacuna @5 15
C03 11  X  FRE  @0 Grippe H1N1 @4 CD @5 96
C03 11  X  ENG  @0 H1N1 influenza @4 CD @5 96
C03 11  X  SPA  @0 Gripe H1N1 @4 CD @5 96
C07 01  X  FRE  @0 Homme
C07 01  X  ENG  @0 Human
C07 01  X  SPA  @0 Hombre
C07 02  X  FRE  @0 Europe @2 NG
C07 02  X  ENG  @0 Europe @2 NG
C07 02  X  SPA  @0 Europa @2 NG
C07 03  X  FRE  @0 Trouble neurologique @5 38
C07 03  X  ENG  @0 Neurological disorder @5 38
C07 03  X  SPA  @0 Trastorno neurológico @5 38
C07 04  X  FRE  @0 Trouble du sommeil @5 39
C07 04  X  ENG  @0 Sleep disorder @5 39
C07 04  X  SPA  @0 Trastorno sueño @5 39
C07 05  X  FRE  @0 Pathologie de l'appareil respiratoire @5 40
C07 05  X  ENG  @0 Respiratory disease @5 40
C07 05  X  SPA  @0 Aparato respiratorio patología @5 40
C07 06  X  FRE  @0 Virose @5 41
C07 06  X  ENG  @0 Viral disease @5 41
C07 06  X  SPA  @0 Virosis @5 41
N21       @1 238
N44 01      @1 OTO
N82       @1 OTO

Links toward previous steps (curation, corpus...)


Links to Exploration step

Pascal:13-0247443

Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<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="1">
<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>
</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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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="1">
<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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Drouot, Xavier" sort="Drouot, Xavier" uniqKey="Drouot X" first="Xavier" last="Drouot">Xavier Drouot</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Bourgin, Patrice" sort="Bourgin, Patrice" uniqKey="Bourgin P" first="Patrice" last="Bourgin">Patrice Bourgin</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Nogues, Beatrice" sort="Nogues, Beatrice" uniqKey="Nogues B" first="Béatrice" last="Nogues">Béatrice Nogues</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<affiliation wicri:level="1">
<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>
</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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">INIST</idno>
<idno type="inist">13-0247443</idno>
<date when="2013">2013</date>
<idno type="stanalyst">PASCAL 13-0247443 INIST</idno>
<idno type="RBID">Pascal:13-0247443</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000253</idno>
<idno type="wicri:Area/PascalFrancis/Curation">001B74</idno>
</publicationStmt>
<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="1">
<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>
</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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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="1">
<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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Drouot, Xavier" sort="Drouot, Xavier" uniqKey="Drouot X" first="Xavier" last="Drouot">Xavier Drouot</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Bourgin, Patrice" sort="Bourgin, Patrice" uniqKey="Bourgin P" first="Patrice" last="Bourgin">Patrice Bourgin</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Nogues, Beatrice" sort="Nogues, Beatrice" uniqKey="Nogues B" first="Béatrice" last="Nogues">Béatrice Nogues</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<affiliation wicri:level="1">
<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>
</affiliation>
</author>
<author>
<name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<affiliation wicri:level="1">
<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>
</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>
</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>
</affiliation>
<affiliation wicri:level="1">
<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>
</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>
</affiliation>
</author>
<author>
<name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<affiliation wicri:level="1">
<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>
</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>
</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>
<inist>
<standard h6="B">
<pA>
<fA01 i1="01" i2="1">
<s0>0006-8950</s0>
</fA01>
<fA03 i2="1">
<s0>Brain</s0>
</fA03>
<fA05>
<s2>136</s2>
</fA05>
<fA06>
<s3>p. 8</s3>
</fA06>
<fA08 i1="01" i2="1" l="ENG">
<s1>Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>DAUVILLIERS (Yves)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>ARNULF (Isabelle)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>LECENDREUX (Michel)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>MONACA CHARLEY (Christelle)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>FRANCO (Patricia)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>DROUOT (Xavier)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>D'ORTHO (Marie-Pia)</s1>
</fA11>
<fA11 i1="08" i2="1">
<s1>LAUNOIS (Sandrine)</s1>
</fA11>
<fA11 i1="09" i2="1">
<s1>LIGNOT (Séverine)</s1>
</fA11>
<fA11 i1="10" i2="1">
<s1>BOURGIN (Patrice)</s1>
</fA11>
<fA11 i1="11" i2="1">
<s1>NOGUES (Béatrice)</s1>
</fA11>
<fA11 i1="12" i2="1">
<s1>REY (Marc)</s1>
</fA11>
<fA11 i1="13" i2="1">
<s1>BAYARD (Sophie)</s1>
</fA11>
<fA11 i1="14" i2="1">
<s1>SCHOLZ (Sabine)</s1>
</fA11>
<fA11 i1="15" i2="1">
<s1>LAVAULT (Sophie)</s1>
</fA11>
<fA11 i1="16" i2="1">
<s1>TUBERT-BITTER (Pascale)</s1>
</fA11>
<fA11 i1="17" i2="1">
<s1>SAUSSIER (Cristel)</s1>
</fA11>
<fA11 i1="18" i2="1">
<s1>PARIENTE (Antoine)</s1>
</fA11>
<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>
</fA14>
<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>
</fA14>
<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>
</fA14>
<fA14 i1="04">
<s1>Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<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>
</fA14>
<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>
</fA14>
<fA14 i1="07">
<s1>Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<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>
</fA14>
<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>
</fA14>
<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>
</fA14>
<fA14 i1="11">
<s1>Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212</s1>
<s2>Strasbourg</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="12">
<s1>Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="13">
<s1>Clinical Neurophysiology Unit, La Timone Hospital</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</fA14>
<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>
</fA14>
<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>
</fA14>
<fA17 i1="01" i2="1">
<s1>Narcoflu-VF study group</s1>
<s3>INC</s3>
</fA17>
<fA20>
<s1>2486-2496</s1>
</fA20>
<fA21>
<s1>2013</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>998</s2>
<s5>354000506516950140</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2013 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>3/4 p.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>13-0247443</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Brain</s0>
</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B17G</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Narcolepsie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Narcolepsy</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Narcolepsia</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Infection</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Infection</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Infección</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Pathologie du système nerveux</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Facteur risque</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Risk factor</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Factor riesgo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Enfant</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Child</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Niño</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Vaccination</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Vaccination</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Vacunación</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>France</s0>
<s2>NG</s2>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>France</s0>
<s2>NG</s2>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Francia</s0>
<s2>NG</s2>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Cataplexie</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Cataplexy</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Cataplexia</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Prévention</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Prevention</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Prevención</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Vaccin</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Vaccine</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Vacuna</s0>
<s5>15</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Grippe H1N1</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>H1N1 influenza</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Gripe H1N1</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Europa</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Trouble neurologique</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Neurological disorder</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Trastorno neurológico</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Trouble du sommeil</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Sleep disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Trastorno sueño</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Pathologie de l'appareil respiratoire</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Respiratory disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Aparato respiratorio patología</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Virose</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Viral disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Virosis</s0>
<s5>41</s5>
</fC07>
<fN21>
<s1>238</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/PandemieGrippaleV1/Data/PascalFrancis/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001B74 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Curation/biblio.hfd -nk 001B74 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

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

Wicri

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