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12 p, 484.6 KB |
Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
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López Fauqued, Marta (GlaxoSmithKline (GSK)) ;
Campora, Laura (GlaxoSmithKline (GSK)) ;
Delannois, Frédérique (GlaxoSmithKline (GSK)) ;
El Idrissi, Mohamed (GlaxoSmithKline (GSK)) ;
Oostvogels, Lidia (GlaxoSmithKline (GSK)) ;
De Looze, Ferdinandus (University of Queensland) ;
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València)) ;
Heineman, Thomas (GlaxoSmithKline (GSK)) ;
Lal, Himal (GlaxoSmithKline (GSK)) ;
McElhaney, Janet (Health Sciences North Research Institute) ;
McNeil, Shelly (Dalhousie University) ;
Yeo, Wilfred (University of Wollongong) ;
Tavares-Da-Silva, Fernanda (GlaxoSmithKline (GSK)) ;
Ahonen, Anitta (University of Tampere) ;
Avelino-Silva, Thiago (University of São Paulo Medical School) ;
Barba-Gomez, José Fernando (Instituto Dermatológico de Jalisco) ;
Berglund, Johan (Blekinge Institute of Technology) ;
Brotons, Carlos (Institut d'Investigació Biomèdica Sant Pau) ;
Caso, Covadonga (Hospital Clínico San Carlos (Madrid)) ;
Chlibek, Roman (University of Defence) ;
Choi, Won Suk (Korea University College of Medicine) ;
Cunningham, Anthony (University of Sydney) ;
Desole, Maria Giuseppina (Servizio di Igiene Pubblica) ;
Eizenberg, Peter (Doctors of Ivanhoe) ;
Esen, Meral (University Clinic of Tübingen) ;
Espié, Emmanuelle (GlaxoSmithKline (GSK)) ;
Gervais, Pierre (Q&T Research Sherbrooke) ;
Ghesquiere, Wayne (University of British Columbia) ;
Godeaux, Olivier O. (GlaxoSmithKline (GSK)) ;
Gorfinkel, Iris (York University) ;
Hui, David Shu Cheong (Prince of Wales Hospital (Australia)) ;
Hwang, Shinnjang (Taipei Veterans General Hospital and National Yang Ming University School of Medicine) ;
Korhonen, Tiina (University of Tampere Medical School) ;
Kovac, Martina (GlaxoSmithKline (GSK)) ;
Ledent, Edouard Y. (GlaxoSmithKline (GSK)) ;
Leung, Edward Man Fuk (Hong Kong Association of Gerontology) ;
Levin, Myron (University of Colorado Anschutz Medical Campus) ;
Perez, Silvia Narejos (CAP Centelles) ;
de Andrade Neto, José Luiz (Instituto A. Z. de Pesquisa e Ensino) ;
Pauksens, Karlis (Uppsala University Hospital) ;
Poder, Airi (Kliiniliste Uuringute Keskus) ;
Rodriguez de la Pinta, Maria Luisa (Hospital Universitario Puerta de Hierro Majadahonda (Madrid)) ;
Rombo, Lars (Uppsala University) ;
Schwarz, Tino Francis (Standort Juliusspital) ;
Smetana, Jan (University of Defence) ;
Staniscia, Tommaso (University G. d'Annunzio of Chieti-Pescara) ;
Tinoco-Fávila, Juan Carlos (Hospital General de Durango) ;
Toma, Azhar (Manna Research) ;
Vastiau, Ilse (GlaxoSmithKline (GSK)) ;
Vesikari, Timo H. (University of Tampere) ;
Volpi, Antonio (A.O. Univesitaria Policlinico Tor Vergata) ;
Watanabe, Daisuke (Kobe University Graduate School of Medicine) ;
Weckx, Lily (Federal University of Sao Paulo) ;
Zahaf, Toufik (GlaxoSmithKline (GSK)) ;
Universitat Autònoma de Barcelona
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. [...]
2019 -  10.1016/j.vaccine.2019.03.043
Vaccine, Vol. 37 Núm. 18 (24 2019) , p. 2482-2493
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7 p, 200.4 KB |
Re-emergence of enterovirus d68 in europe after easing the covid-19 lockdown, september 2021
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Benschop, Kimberley S. M (Laboratory Medicine. Molecular Microbiology) ;
Albert, Jan (Karolinska Institutet (Estocolm, Suècia)) ;
Antón, Andrés (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Andrés, Cristina (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Aranzamendi, Maitane (Biodonostia Osasun Ikerketako Institutura (País Basc)) ;
Armannsdottir, Brynja (Landspitali-National University Hospital) ;
Bailly, Jean-Luc (Université d'Auvergne) ;
Baldanti, Fausto (Università degli Studi di Pavia) ;
Baldvinsdottir, Guðrún Erna (Landspitali-National University Hospital) ;
Beard, Stuart (Laboratory Medicine. Molecular Microbiology) ;
Berginc, Natasa (Laboratory Medicine. Molecular Microbiology) ;
Bottcher, Sindy (Laboratory Medicine. Molecular Microbiology) ;
Blomqvist, Soile (Laboratory Medicine. Molecular Microbiology) ;
Bubba, Laura (Laboratory Medicine. Molecular Microbiology) ;
Calvo, Cristina (Hospital Universitario La Paz (Madrid)) ;
Cabrerizo, María (Laboratory Medicine. Molecular Microbiology) ;
Cavallero, Annalisa (Laboratory Medicine. Molecular Microbiology) ;
Celma, Cristina (Laboratory Medicine. Molecular Microbiology) ;
Ceriotti, Ferruccio (Laboratory Medicine. Molecular Microbiology) ;
Costa, Inês (Laboratory Medicine. Molecular Microbiology) ;
Cottrell, Simon (Laboratory Medicine. Molecular Microbiology) ;
Del Cuerpo, Margarita (Universitat Autònoma de Barcelona) ;
Dean, Jonathan (Laboratory Medicine. Molecular Microbiology) ;
Dembinski, Jennifer L (Laboratory Medicine. Molecular Microbiology) ;
Diedrich, Sabine (Laboratory Medicine. Molecular Microbiology) ;
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València)) ;
Dorenberg, DagnyHaug (Laboratory Medicine. Molecular Microbiology) ;
Duizer, Erwin (Laboratory Medicine. Molecular Microbiology) ;
Dyrdak, Robert (Laboratory Medicine. Molecular Microbiology) ;
Fanti, Diana (Laboratory Medicine. Molecular Microbiology) ;
Farkas, Agnes (Laboratory Medicine. Molecular Microbiology) ;
Feeney, Susan (Laboratory Medicine. Molecular Microbiology) ;
Flipse, Jacky (Laboratory Medicine. Molecular Microbiology) ;
De Gascun, Cillian (Laboratory Medicine. Molecular Microbiology) ;
Galli, Cristina (Laboratory Medicine. Molecular Microbiology) ;
Georgieva, Irina (Laboratory Medicine. Molecular Microbiology) ;
Gifford, Laura (Laboratory Medicine. Molecular Microbiology) ;
Guiomar, Raquel (Laboratory Medicine. Molecular Microbiology) ;
Honemann, Mario (Laboratory Medicine. Molecular Microbiology) ;
Ikonen, Niina (Laboratory Medicine. Molecular Microbiology) ;
Jeannoel, Marion (Laboratory Medicine. Molecular Microbiology) ;
Josset, Laurence (Laboratory Medicine. Molecular Microbiology) ;
Keeren, Kathrin (Laboratory Medicine. Molecular Microbiology) ;
Lopez-Labrador, F. Xavier (Laboratory Medicine. Molecular Microbiology) ;
Maier, Melanie (Laboratory Medicine. Molecular Microbiology) ;
McKenna, James (Laboratory Medicine. Molecular Microbiology) ;
Meijer, Adam (Laboratory Medicine. Molecular Microbiology) ;
Mengual-Chulia, Beatriz (Laboratory Medicine. Molecular Microbiology) ;
Midgley, Sofie E. (Laboratory Medicine. Molecular Microbiology) ;
Mirand, Audry (Laboratory Medicine. Molecular Microbiology) ;
Montes, Milagrosa (Laboratory Medicine. Molecular Microbiology) ;
Moore, Catherine (Laboratory Medicine. Molecular Microbiology) ;
Morley, Ursula (Laboratory Medicine. Molecular Microbiology) ;
Murk, Jean-Luc (Laboratory Medicine. Molecular Microbiology) ;
Nikolaeva-Glomb, Lubomira (Laboratory Medicine. Molecular Microbiology) ;
Numanovic, Sanela (Laboratory Medicine. Molecular Microbiology) ;
Oggioni, Massimo (Laboratory Medicine. Molecular Microbiology) ;
Palminha, Paula (Laboratory Medicine. Molecular Microbiology) ;
Pariani, Elena (Laboratory Medicine. Molecular Microbiology) ;
Pellegrinelli, Laura (Laboratory Medicine. Molecular Microbiology) ;
Piralla, Antonio (Laboratory Medicine. Molecular Microbiology) ;
Pietsch, Corinna (Laboratory Medicine. Molecular Microbiology) ;
Pineiro, Luis (Laboratory Medicine. Molecular Microbiology) ;
Rabella, Núria (Institut d'Investigació Biomèdica Sant Pau) ;
Rainetova, Petra (Laboratory Medicine. Molecular Microbiology) ;
Renteria, Sara Colonia Uceda (Laboratory Medicine. Molecular Microbiology) ;
Romero, María P. (Laboratory Medicine. Molecular Microbiology) ;
Reynders, Marijke (Laboratory Medicine. Molecular Microbiology) ;
Roorda, Lieuwe (Maasstad Hospital) ;
Savolainen-Kopra, Carita (Laboratory Medicine. Molecular Microbiology) ;
Schuffenecker, Isabelle (Laboratory Medicine. Molecular Microbiology) ;
Soynova, Aysa (Laboratory Medicine. Molecular Microbiology) ;
Swanink, Caroline M. (Laboratory Medicine. Molecular Microbiology) ;
Ursic, Tina (Institute of Microbiology and Immunology. Faculty of Medicine. University of Ljubljana) ;
Verweij, Jaco J. (Laboratory Medicine. Molecular Microbiology) ;
Vila, Jorgina (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Vuorinen, Tytti (Clinical Microbiology. Turku University Hospital and Institute of Biomedicine. University of Turku) ;
Simmonds, Peter (University of Oxford) ;
Fischer, Thea K. (Nordsjaellands Hospital) ;
Harvala, Heli (University College London (UCL). Department of infection and Immunity) ;
Universitat Autònoma de Barcelona
We report a rapid increase in enterovirus D68 (EVD68) infections, with 139 cases reported from eight European countries between 31 July and 14 October 2021. This upsurge is in line with the seasonality of EV-D68 and was presumably stimulated by the widespread reopening after COVID-19 lockdown. [...]
2021 - 10.2807/1560-7917.ES.2021.26.45.2100998
Eurosurveillance, Vol. 26 Núm. 45 (january 2021) , p. pii=2100998
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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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