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15 p, 2.7 MB |
Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe : The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
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Dodd, Caitlin N. (Erasmus Medical Center (Rotterdam)) ;
de Ridder, Maria A. J. (Erasmus Medical Center (Rotterdam)) ;
Huang, Wan-Ting (Taiwan Centers for Disease Control) ;
Weibel, Daniel (Erasmus Medical Center (Rotterdam)) ;
Giner-Soriano, Maria (Universitat Autònoma de Barcelona) ;
Perez-Vilar, Silvia (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València)) ;
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València)) ;
Svenson, Lawrence W. (University of Alberta) ;
Mahmud, Salaheddin M (University of Manitoba) ;
Carleton, Bruce (University of British Columbia) ;
Naus, Monika (University of British Columbia) ;
Kwong, Jeffrey C. (University Health Network (Toronto)) ;
Murray, Brian J. (Sunnybrook Health Sciences Centre (Toronto)) ;
Arnheim-Dahlström, Lisen (Karolinska Institutet (Estocolm, Suècia). Department of Medical Epidemiology and Biostatistics) ;
Pedersen, Lars (Aarhus University. Department of Clinical Epidemiology) ;
Morros, Rosa (Universitat Autònoma de Barcelona) ;
Puertas, Francisco Javier (University of Valencia. Physiology Department) ;
Black, Steven (Cincinnati Children's Hospital Medical Center) ;
Sturkenboom, Miriam (University Medical Center Utrecht. Julius Center Global Health)
Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. [...]
2018 -  10.1371/journal.pone.0204799
PloS one, Vol. 13 Núm. 10 (october 2018)
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22 p, 620.6 KB |
Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment
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Weibel, Daniel (Erasmus Medical Center (Rotterdam, Països Baixos)) ;
Sturkenboom, Miriam (University Utrecht Medical Center) ;
Black, Steven (Cincinnati Children's Hospital Medical Center) ;
de Ridder, Maria A. J. (Erasmus Medical Center (Rotterdam, Països Baixos)) ;
Dodd, Caitlin (Erasmus Medical Center (Rotterdam, Països Baixos)) ;
Bonhoeffer, Jan (Brighton Collaboration Foundation (Basilea, Suïssa)) ;
Vanrolleghem, Ann (Erasmus Medical Center (Rotterdam, Països Baixos)) ;
van der Maas, Nicoline (National Institute for Public Health and the Environment (Bilthoven, Països Baixos)) ;
Lammers, Gert Jan (Sleep-Wake Center SEIN (Heemstede, Països Baixos)) ;
Overeem, Sebastiaan (Sleep Medicine Centre Kempenhaeghe (Heeze, Països Baixos)) ;
Gentile, Angela (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina)) ;
Giglio, Norberto (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina)) ;
Castellano, Vanesa (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina)) ;
Kwong, Jeffrey C. (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada)) ;
Murray, Brian J. (University of Toronto) ;
Cauch-Dudek, Karen (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada)) ;
Juhasz, Diana (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada)) ;
Campitelli, Michael (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada)) ;
Datta, Alexandre N. (University Hospital Basel (Basilea, Suïssa)) ;
Kallweit, Ulf (Witten/Herdecke University) ;
Huang, Wan-Ting (Taiwan Centers for Disease Control) ;
Huang, Yu-Shu (Chang Gung Memorial Hospital (Taiwan). Department of Child Psychiatry and Sleep Center) ;
Hsu, Chung-Yao (Kaohsiung Medical University Hospital (Kaohsiung, Taiwan)) ;
Chen, Hsi-Chung (National Taiwan University Hospital (Taipei, Taiwan)) ;
Giner-Soriano, Maria (Institut Universitari d'Investigació en Atenció Primària Jordi Gol) ;
Morros, Rosa (Institut Universitari d'Investigació en Atenció Primària Jordi Gol) ;
Gaig, Carles (Hospital Clínic i Provincial de Barcelona) ;
Tió, Ester (Althaia Xarxa Assistencial Universitària de Manresa (Manresa, Catalunya)) ;
Perez-Vilar, Silvia (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat -FISABIO (València)) ;
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València)) ;
Puertas, Francisco Javier (Hospital Universitari de la Ribera (València)) ;
Svenson, Lawrence W. (University of Alberta (Alberta, Canada). Division of Preventive Medicine) ;
Mahmud, Salaheddin M. (University of Manitoba (Manitoba, Canada). Rady Faculty of Health Sciences) ;
Carleton, Bruce (University of British Columbia. Faculty of Medicine) ;
Naus, Monika (University of British Columbia. Faculty of Medicine) ;
Arnheim-Dahlström, Lisen (Karolinska Institutet (Estocolm, Suècia). Department of Medical Epidemiology and Biostatistics) ;
Pedersen, Lars (Aarhus University (Aarhus, Dinamarca)) ;
DeStefano, Frank (Centers for Disease Control and Prevention-CDC (Atlanta, Estats Units d'Amèrica)) ;
Shimabukuro, Tom T. (Centers for Disease Control and Prevention-CDC (Atlanta, Estats Units d'Amèrica)) ;
Universitat Autònoma de Barcelona
In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines. [...]
2018 - 10.1016/j.vaccine.2018.08.008
Vaccine, Vol. 36 (august 2018) , p. 6202-6211
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