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The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Identifieur interne : 000344 ( PascalFrancis/Corpus ); précédent : 000343; suivant : 000345

The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Auteurs : Leonoor Wijnans ; Coralie Lecomte ; Corinne De Vries ; Daniel Weibel ; Cormac Sammon ; Anders Hviid ; Henrik Svanström ; Ditte M Lgaard-Nielsen ; Harald Heijbel ; Lisen Arnheim Dahlström ; Jonas Hallgren ; Par Sparen ; Poul Jennum ; Mees Mosseveld ; Martijn Schuemie ; Nicoline Van Der Maas ; Markku Partinen ; Silvana Romio ; Francesco Trotta ; Carmela Santuccio ; Angelo Menna ; Giuseppe Plazzi ; Keivan Kaveh Moghadam ; Salvatore Ferro ; Gertjan Lammers ; Sebastiaan Overeem ; Kari Johansen ; Piotr Kramarz ; Jan Bonhoeffer ; Miriam C. J. M. Sturkenboom

Source :

RBID : Pascal:13-0117033

Descripteurs français

English descriptors

Abstract

Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

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Pour connaître la documentation sur le format Inist Standard.

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A14 15      @1 Leiden University Medical Center @2 Leiden @3 NLD @Z 25 aut.
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C01 01    ENG  @0 Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.
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Format Inist (serveur)

NO : PASCAL 13-0117033 INIST
ET : The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns
AU : WIJNANS (Leonoor); LECOMTE (Coralie); DE VRIES (Corinne); WEIBEL (Daniel); SAMMON (Cormac); HVIID (Anders); SVANSTRÖM (Henrik); MØLGAARD-NIELSEN (Ditte); HEIJBEL (Harald); ARNHEIM DAHLSTRÖM (Lisen); HALLGREN (Jonas); SPAREN (Par); JENNUM (Poul); MOSSEVELD (Mees); SCHUEMIE (Martijn); VAN DER MAAS (Nicoline); PARTINEN (Markku); ROMIO (Silvana); TROTTA (Francesco); SANTUCCIO (Carmela); MENNA (Angelo); PLAZZI (Giuseppe); KAVEH MOGHADAM (Keivan); FERRO (Salvatore); LAMMERS (Gertjan); OVEREEM (Sebastiaan); JOHANSEN (Kari); KRAMARZ (Piotr); BONHOEFFER (Jan); STURKENBOOM (Miriam C. J. M.)
AF : Erasmus University Medical Center/Rotterdam/Pays-Bas (1 aut., 2 aut., 4 aut., 14 aut., 15 aut., 18 aut., 30 aut.); Medicines Evaluation Board/Pays-Bas (1 aut.); University of Bath/Bath/Royaume-Uni (3 aut., 5 aut.); Brighton Collaboration Foundation/Basel/Suisse (4 aut., 29 aut.); Statens Serum Institut/Copenhagen/Danemark (6 aut., 7 aut., 8 aut.); Swedish Institute for Infectious Disease Control/Lund/Suède (9 aut.); The Karolinska Institute/Stockholm/Suède (10 aut., 11 aut., 12 aut.); Danish Center for Sleep Medicine/Copenhagen/Danemark (13 aut.); National Institute of Public Health/Bilthoven/Pays-Bas (16 aut.); Helsingin Uniklinikka/Helsinki/Finlande (17 aut.); Italian Medicines Agency/Rome/Italie (19 aut., 20 aut.); Regional Health Authority/Tuscany/Italie (21 aut.); Department of Neurological Sciences, University of Bologna/, Bologna/Italie (22 aut., 23 aut.); Regional Health Authority/Emilia Romagna/Italie (24 aut.); Leiden University Medical Center/Leiden/Pays-Bas (25 aut.); Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101/6500 HB Nijmegen/Pays-Bas (26 aut.); European Centre for Disease Prevention and Control/Stockholm/Suède (27 aut., 28 aut.); University Children's Hospital/Basel/Suisse (29 aut.)
DT : Publication en série; Niveau analytique
SO : Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2013; Vol. 31; No. 8; Pp. 1246-1254; Bibl. 44 ref.
LA : Anglais
EA : Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.
CC : 002A05F04; 002A05C10
FD : Virus grippal A; Incidence; Epidémiologie; Narcolepsie; Europe; Vaccination; Vaccin; Adjuvant immunologique; Grippe A
FG : Influenzavirus A; Orthomyxoviridae; Virus; Pathologie du système nerveux; Virose; Infection; Trouble neurologique; Trouble du sommeil
ED : Influenza A virus; Incidence; Epidemiology; Narcolepsy; Europe; Vaccination; Vaccine; Immunological adjuvant; Influenza A
EG : Influenzavirus A; Orthomyxoviridae; Virus; Nervous system diseases; Viral disease; Infection; Neurological disorder; Sleep disorder
SD : Influenza A virus; Incidencia; Epidemiología; Narcolepsia; Europa; Vacunación; Vacuna; Coadyuvante inmunológico; Gripe A
LO : INIST-20289.354000173213250160
ID : 13-0117033

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<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
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<sZ>1 aut.</sZ>
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<sZ>15 aut.</sZ>
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<name sortKey="Van Der Maas, Nicoline" sort="Van Der Maas, Nicoline" uniqKey="Van Der Maas N" first="Nicoline" last="Van Der Maas">Nicoline Van Der Maas</name>
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<inist:fA14 i1="09">
<s1>National Institute of Public Health</s1>
<s2>Bilthoven</s2>
<s3>NLD</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
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</author>
<author>
<name sortKey="Partinen, Markku" sort="Partinen, Markku" uniqKey="Partinen M" first="Markku" last="Partinen">Markku Partinen</name>
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<s1>Helsingin Uniklinikka</s1>
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<sZ>17 aut.</sZ>
</inist:fA14>
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</author>
<author>
<name sortKey="Romio, Silvana" sort="Romio, Silvana" uniqKey="Romio S" first="Silvana" last="Romio">Silvana Romio</name>
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<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
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</author>
<author>
<name sortKey="Trotta, Francesco" sort="Trotta, Francesco" uniqKey="Trotta F" first="Francesco" last="Trotta">Francesco Trotta</name>
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<inist:fA14 i1="11">
<s1>Italian Medicines Agency</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Santuccio, Carmela" sort="Santuccio, Carmela" uniqKey="Santuccio C" first="Carmela" last="Santuccio">Carmela Santuccio</name>
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<inist:fA14 i1="11">
<s1>Italian Medicines Agency</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
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</author>
<author>
<name sortKey="Menna, Angelo" sort="Menna, Angelo" uniqKey="Menna A" first="Angelo" last="Menna">Angelo Menna</name>
<affiliation>
<inist:fA14 i1="12">
<s1>Regional Health Authority</s1>
<s2>Tuscany</s2>
<s3>ITA</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Plazzi, Giuseppe" sort="Plazzi, Giuseppe" uniqKey="Plazzi G" first="Giuseppe" last="Plazzi">Giuseppe Plazzi</name>
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<inist:fA14 i1="13">
<s1>Department of Neurological Sciences, University of Bologna</s1>
<s2>, Bologna</s2>
<s3>ITA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kaveh Moghadam, Keivan" sort="Kaveh Moghadam, Keivan" uniqKey="Kaveh Moghadam K" first="Keivan" last="Kaveh Moghadam">Keivan Kaveh Moghadam</name>
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<inist:fA14 i1="13">
<s1>Department of Neurological Sciences, University of Bologna</s1>
<s2>, Bologna</s2>
<s3>ITA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Ferro, Salvatore" sort="Ferro, Salvatore" uniqKey="Ferro S" first="Salvatore" last="Ferro">Salvatore Ferro</name>
<affiliation>
<inist:fA14 i1="14">
<s1>Regional Health Authority</s1>
<s2>Emilia Romagna</s2>
<s3>ITA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Lammers, Gertjan" sort="Lammers, Gertjan" uniqKey="Lammers G" first="Gertjan" last="Lammers">Gertjan Lammers</name>
<affiliation>
<inist:fA14 i1="15">
<s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>25 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Overeem, Sebastiaan" sort="Overeem, Sebastiaan" uniqKey="Overeem S" first="Sebastiaan" last="Overeem">Sebastiaan Overeem</name>
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<inist:fA14 i1="16">
<s1>Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101</s1>
<s2>6500 HB Nijmegen</s2>
<s3>NLD</s3>
<sZ>26 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Johansen, Kari" sort="Johansen, Kari" uniqKey="Johansen K" first="Kari" last="Johansen">Kari Johansen</name>
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<inist:fA14 i1="17">
<s1>European Centre for Disease Prevention and Control</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>27 aut.</sZ>
<sZ>28 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kramarz, Piotr" sort="Kramarz, Piotr" uniqKey="Kramarz P" first="Piotr" last="Kramarz">Piotr Kramarz</name>
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<s1>European Centre for Disease Prevention and Control</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>27 aut.</sZ>
<sZ>28 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Bonhoeffer, Jan" sort="Bonhoeffer, Jan" uniqKey="Bonhoeffer J" first="Jan" last="Bonhoeffer">Jan Bonhoeffer</name>
<affiliation>
<inist:fA14 i1="04">
<s1>Brighton Collaboration Foundation</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation>
<inist:fA14 i1="18">
<s1>University Children's Hospital</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>29 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Sturkenboom, Miriam C J M" sort="Sturkenboom, Miriam C J M" uniqKey="Sturkenboom M" first="Miriam C. J. M." last="Sturkenboom">Miriam C. J. M. Sturkenboom</name>
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<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
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<title xml:lang="en" level="a">The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns</title>
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<name sortKey="Wijnans, Leonoor" sort="Wijnans, Leonoor" uniqKey="Wijnans L" first="Leonoor" last="Wijnans">Leonoor Wijnans</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation>
<inist:fA14 i1="02">
<s1>Medicines Evaluation Board</s1>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Lecomte, Coralie" sort="Lecomte, Coralie" uniqKey="Lecomte C" first="Coralie" last="Lecomte">Coralie Lecomte</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
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<sZ>18 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="De Vries, Corinne" sort="De Vries, Corinne" uniqKey="De Vries C" first="Corinne" last="De Vries">Corinne De Vries</name>
<affiliation>
<inist:fA14 i1="03">
<s1>University of Bath</s1>
<s2>Bath</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Weibel, Daniel" sort="Weibel, Daniel" uniqKey="Weibel D" first="Daniel" last="Weibel">Daniel Weibel</name>
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<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation>
<inist:fA14 i1="04">
<s1>Brighton Collaboration Foundation</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Sammon, Cormac" sort="Sammon, Cormac" uniqKey="Sammon C" first="Cormac" last="Sammon">Cormac Sammon</name>
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<inist:fA14 i1="03">
<s1>University of Bath</s1>
<s2>Bath</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Hviid, Anders" sort="Hviid, Anders" uniqKey="Hviid A" first="Anders" last="Hviid">Anders Hviid</name>
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<inist:fA14 i1="05">
<s1>Statens Serum Institut</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Svanstrom, Henrik" sort="Svanstrom, Henrik" uniqKey="Svanstrom H" first="Henrik" last="Svanström">Henrik Svanström</name>
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<inist:fA14 i1="05">
<s1>Statens Serum Institut</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="M Lgaard Nielsen, Ditte" sort="M Lgaard Nielsen, Ditte" uniqKey="M Lgaard Nielsen D" first="Ditte" last="M Lgaard-Nielsen">Ditte M Lgaard-Nielsen</name>
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<inist:fA14 i1="05">
<s1>Statens Serum Institut</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Heijbel, Harald" sort="Heijbel, Harald" uniqKey="Heijbel H" first="Harald" last="Heijbel">Harald Heijbel</name>
<affiliation>
<inist:fA14 i1="06">
<s1>Swedish Institute for Infectious Disease Control</s1>
<s2>Lund</s2>
<s3>SWE</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Arnheim Dahlstrom, Lisen" sort="Arnheim Dahlstrom, Lisen" uniqKey="Arnheim Dahlstrom L" first="Lisen" last="Arnheim Dahlström">Lisen Arnheim Dahlström</name>
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<inist:fA14 i1="07">
<s1>The Karolinska Institute</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Hallgren, Jonas" sort="Hallgren, Jonas" uniqKey="Hallgren J" first="Jonas" last="Hallgren">Jonas Hallgren</name>
<affiliation>
<inist:fA14 i1="07">
<s1>The Karolinska Institute</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Sparen, Par" sort="Sparen, Par" uniqKey="Sparen P" first="Par" last="Sparen">Par Sparen</name>
<affiliation>
<inist:fA14 i1="07">
<s1>The Karolinska Institute</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Jennum, Poul" sort="Jennum, Poul" uniqKey="Jennum P" first="Poul" last="Jennum">Poul Jennum</name>
<affiliation>
<inist:fA14 i1="08">
<s1>Danish Center for Sleep Medicine</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Mosseveld, Mees" sort="Mosseveld, Mees" uniqKey="Mosseveld M" first="Mees" last="Mosseveld">Mees Mosseveld</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Schuemie, Martijn" sort="Schuemie, Martijn" uniqKey="Schuemie M" first="Martijn" last="Schuemie">Martijn Schuemie</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Van Der Maas, Nicoline" sort="Van Der Maas, Nicoline" uniqKey="Van Der Maas N" first="Nicoline" last="Van Der Maas">Nicoline Van Der Maas</name>
<affiliation>
<inist:fA14 i1="09">
<s1>National Institute of Public Health</s1>
<s2>Bilthoven</s2>
<s3>NLD</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Partinen, Markku" sort="Partinen, Markku" uniqKey="Partinen M" first="Markku" last="Partinen">Markku Partinen</name>
<affiliation>
<inist:fA14 i1="10">
<s1>Helsingin Uniklinikka</s1>
<s2>Helsinki</s2>
<s3>FIN</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Romio, Silvana" sort="Romio, Silvana" uniqKey="Romio S" first="Silvana" last="Romio">Silvana Romio</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Trotta, Francesco" sort="Trotta, Francesco" uniqKey="Trotta F" first="Francesco" last="Trotta">Francesco Trotta</name>
<affiliation>
<inist:fA14 i1="11">
<s1>Italian Medicines Agency</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Santuccio, Carmela" sort="Santuccio, Carmela" uniqKey="Santuccio C" first="Carmela" last="Santuccio">Carmela Santuccio</name>
<affiliation>
<inist:fA14 i1="11">
<s1>Italian Medicines Agency</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Menna, Angelo" sort="Menna, Angelo" uniqKey="Menna A" first="Angelo" last="Menna">Angelo Menna</name>
<affiliation>
<inist:fA14 i1="12">
<s1>Regional Health Authority</s1>
<s2>Tuscany</s2>
<s3>ITA</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Plazzi, Giuseppe" sort="Plazzi, Giuseppe" uniqKey="Plazzi G" first="Giuseppe" last="Plazzi">Giuseppe Plazzi</name>
<affiliation>
<inist:fA14 i1="13">
<s1>Department of Neurological Sciences, University of Bologna</s1>
<s2>, Bologna</s2>
<s3>ITA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kaveh Moghadam, Keivan" sort="Kaveh Moghadam, Keivan" uniqKey="Kaveh Moghadam K" first="Keivan" last="Kaveh Moghadam">Keivan Kaveh Moghadam</name>
<affiliation>
<inist:fA14 i1="13">
<s1>Department of Neurological Sciences, University of Bologna</s1>
<s2>, Bologna</s2>
<s3>ITA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Ferro, Salvatore" sort="Ferro, Salvatore" uniqKey="Ferro S" first="Salvatore" last="Ferro">Salvatore Ferro</name>
<affiliation>
<inist:fA14 i1="14">
<s1>Regional Health Authority</s1>
<s2>Emilia Romagna</s2>
<s3>ITA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Lammers, Gertjan" sort="Lammers, Gertjan" uniqKey="Lammers G" first="Gertjan" last="Lammers">Gertjan Lammers</name>
<affiliation>
<inist:fA14 i1="15">
<s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>25 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Overeem, Sebastiaan" sort="Overeem, Sebastiaan" uniqKey="Overeem S" first="Sebastiaan" last="Overeem">Sebastiaan Overeem</name>
<affiliation>
<inist:fA14 i1="16">
<s1>Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101</s1>
<s2>6500 HB Nijmegen</s2>
<s3>NLD</s3>
<sZ>26 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Johansen, Kari" sort="Johansen, Kari" uniqKey="Johansen K" first="Kari" last="Johansen">Kari Johansen</name>
<affiliation>
<inist:fA14 i1="17">
<s1>European Centre for Disease Prevention and Control</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>27 aut.</sZ>
<sZ>28 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kramarz, Piotr" sort="Kramarz, Piotr" uniqKey="Kramarz P" first="Piotr" last="Kramarz">Piotr Kramarz</name>
<affiliation>
<inist:fA14 i1="17">
<s1>European Centre for Disease Prevention and Control</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>27 aut.</sZ>
<sZ>28 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Bonhoeffer, Jan" sort="Bonhoeffer, Jan" uniqKey="Bonhoeffer J" first="Jan" last="Bonhoeffer">Jan Bonhoeffer</name>
<affiliation>
<inist:fA14 i1="04">
<s1>Brighton Collaboration Foundation</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation>
<inist:fA14 i1="18">
<s1>University Children's Hospital</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>29 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Sturkenboom, Miriam C J M" sort="Sturkenboom, Miriam C J M" uniqKey="Sturkenboom M" first="Miriam C. J. M." last="Sturkenboom">Miriam C. J. M. Sturkenboom</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint>
<date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Epidemiology</term>
<term>Europe</term>
<term>Immunological adjuvant</term>
<term>Incidence</term>
<term>Influenza A</term>
<term>Influenza A virus</term>
<term>Narcolepsy</term>
<term>Vaccination</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Virus grippal A</term>
<term>Incidence</term>
<term>Epidémiologie</term>
<term>Narcolepsie</term>
<term>Europe</term>
<term>Vaccination</term>
<term>Vaccin</term>
<term>Adjuvant immunologique</term>
<term>Grippe A</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.</div>
</front>
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<s1>The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns</s1>
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<s1>KAVEH MOGHADAM (Keivan)</s1>
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<s1>KRAMARZ (Piotr)</s1>
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<s1>BONHOEFFER (Jan)</s1>
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<s1>STURKENBOOM (Miriam C. J. M.)</s1>
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<fA14 i1="01">
<s1>Erasmus University Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>30 aut.</sZ>
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<fA14 i1="02">
<s1>Medicines Evaluation Board</s1>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
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<fA14 i1="03">
<s1>University of Bath</s1>
<s2>Bath</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Brighton Collaboration Foundation</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
<sZ>29 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>Statens Serum Institut</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="06">
<s1>Swedish Institute for Infectious Disease Control</s1>
<s2>Lund</s2>
<s3>SWE</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="07">
<s1>The Karolinska Institute</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="08">
<s1>Danish Center for Sleep Medicine</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="09">
<s1>National Institute of Public Health</s1>
<s2>Bilthoven</s2>
<s3>NLD</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="10">
<s1>Helsingin Uniklinikka</s1>
<s2>Helsinki</s2>
<s3>FIN</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="11">
<s1>Italian Medicines Agency</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</fA14>
<fA14 i1="12">
<s1>Regional Health Authority</s1>
<s2>Tuscany</s2>
<s3>ITA</s3>
<sZ>21 aut.</sZ>
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<fA14 i1="13">
<s1>Department of Neurological Sciences, University of Bologna</s1>
<s2>, Bologna</s2>
<s3>ITA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="14">
<s1>Regional Health Authority</s1>
<s2>Emilia Romagna</s2>
<s3>ITA</s3>
<sZ>24 aut.</sZ>
</fA14>
<fA14 i1="15">
<s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>25 aut.</sZ>
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<fA14 i1="16">
<s1>Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101</s1>
<s2>6500 HB Nijmegen</s2>
<s3>NLD</s3>
<sZ>26 aut.</sZ>
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<fA14 i1="17">
<s1>European Centre for Disease Prevention and Control</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>27 aut.</sZ>
<sZ>28 aut.</sZ>
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<s1>University Children's Hospital</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>29 aut.</sZ>
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<s1>1246-1254</s1>
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<s1>P</s1>
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<s0>Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.</s0>
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<ET>The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns</ET>
<AU>WIJNANS (Leonoor); LECOMTE (Coralie); DE VRIES (Corinne); WEIBEL (Daniel); SAMMON (Cormac); HVIID (Anders); SVANSTRÖM (Henrik); MØLGAARD-NIELSEN (Ditte); HEIJBEL (Harald); ARNHEIM DAHLSTRÖM (Lisen); HALLGREN (Jonas); SPAREN (Par); JENNUM (Poul); MOSSEVELD (Mees); SCHUEMIE (Martijn); VAN DER MAAS (Nicoline); PARTINEN (Markku); ROMIO (Silvana); TROTTA (Francesco); SANTUCCIO (Carmela); MENNA (Angelo); PLAZZI (Giuseppe); KAVEH MOGHADAM (Keivan); FERRO (Salvatore); LAMMERS (Gertjan); OVEREEM (Sebastiaan); JOHANSEN (Kari); KRAMARZ (Piotr); BONHOEFFER (Jan); STURKENBOOM (Miriam C. J. M.)</AU>
<AF>Erasmus University Medical Center/Rotterdam/Pays-Bas (1 aut., 2 aut., 4 aut., 14 aut., 15 aut., 18 aut., 30 aut.); Medicines Evaluation Board/Pays-Bas (1 aut.); University of Bath/Bath/Royaume-Uni (3 aut., 5 aut.); Brighton Collaboration Foundation/Basel/Suisse (4 aut., 29 aut.); Statens Serum Institut/Copenhagen/Danemark (6 aut., 7 aut., 8 aut.); Swedish Institute for Infectious Disease Control/Lund/Suède (9 aut.); The Karolinska Institute/Stockholm/Suède (10 aut., 11 aut., 12 aut.); Danish Center for Sleep Medicine/Copenhagen/Danemark (13 aut.); National Institute of Public Health/Bilthoven/Pays-Bas (16 aut.); Helsingin Uniklinikka/Helsinki/Finlande (17 aut.); Italian Medicines Agency/Rome/Italie (19 aut., 20 aut.); Regional Health Authority/Tuscany/Italie (21 aut.); Department of Neurological Sciences, University of Bologna/, Bologna/Italie (22 aut., 23 aut.); Regional Health Authority/Emilia Romagna/Italie (24 aut.); Leiden University Medical Center/Leiden/Pays-Bas (25 aut.); Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101/6500 HB Nijmegen/Pays-Bas (26 aut.); European Centre for Disease Prevention and Control/Stockholm/Suède (27 aut., 28 aut.); University Children's Hospital/Basel/Suisse (29 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2013; Vol. 31; No. 8; Pp. 1246-1254; Bibl. 44 ref.</SO>
<LA>Anglais</LA>
<EA>Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.</EA>
<CC>002A05F04; 002A05C10</CC>
<FD>Virus grippal A; Incidence; Epidémiologie; Narcolepsie; Europe; Vaccination; Vaccin; Adjuvant immunologique; Grippe A</FD>
<FG>Influenzavirus A; Orthomyxoviridae; Virus; Pathologie du système nerveux; Virose; Infection; Trouble neurologique; Trouble du sommeil</FG>
<ED>Influenza A virus; Incidence; Epidemiology; Narcolepsy; Europe; Vaccination; Vaccine; Immunological adjuvant; Influenza A</ED>
<EG>Influenzavirus A; Orthomyxoviridae; Virus; Nervous system diseases; Viral disease; Infection; Neurological disorder; Sleep disorder</EG>
<SD>Influenza A virus; Incidencia; Epidemiología; Narcolepsia; Europa; Vacunación; Vacuna; Coadyuvante inmunológico; Gripe A</SD>
<LO>INIST-20289.354000173213250160</LO>
<ID>13-0117033</ID>
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