Methods and operational framework of GALFLU: Individually randomized pragmatic controlled trial of high- versus standard-dose influenza vaccination in older adults.

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Title: Methods and operational framework of GALFLU: Individually randomized pragmatic controlled trial of high- versus standard-dose influenza vaccination in older adults.
Authors: Mallah N; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBER-ESP), Madrid, Spain; Department of Preventive Medicine and Institute of Psychology (IPISUS), University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain., Pardo-Seco J; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; GenPoB Research Group, Instituto de Investigación Sanitaria (IDIS), Hospital Clínico Universitario de Santiago (SERGAS), and INCIFOR, Universidade de Santiago de Compostela (USC), 15706 Santiago de Compostela, Galicia, Spain., Rodriguez-Tenreiro-Sánchez C; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain., Giné-Vázquez I; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain., Mirás-Carballal S; Galician Center for Disease Control and Prevention (CEGACE). Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., Piñeiro-Sotelo M; Galician Center for Disease Control and Prevention (CEGACE). Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., Cribeiro-González M; Department of Communicable Diseases, Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., Conde-Pájaro M; Dirección Xeral de Recursos Económicos, Servizo Galego de Saúde, Xunta de Galicia, Galicia, Spain.Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., González-Pérez JM; Subdirección de Sistemas y Tecnologías de la Información, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., Razzini JL; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain., Rivero-Calle I; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain., Dacosta-Urbieta AI; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain., Harris RC; Sanofi Vaccines, Singapore., Loiacono MM; Department of Epidemiology, University of Delaware, Newark, DE, USA., van Aalst R; Sanofi Vaccines, Morristown, NJ, USA., Farre JM; Sanofi Vaccines, Barcelona, Spain., Dufournet M; Sanofi Vaccines, Lyon, France., Johansen ND; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark., Modin D; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark., Biering-Sørensen T; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Herlev, Denmark., Duran-Parrondo C; Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain., Martinón-Torres F; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain. Electronic address: federico.martinon.torres@sergas.es.
Corporate Authors: GALFLU trial team
Source: Vaccine [Vaccine] 2026 Apr 19; Vol. 79, pp. 128435. Date of Electronic Publication: 2026 Mar 09.
Publication Type: Journal Article; Pragmatic Clinical Trial; Randomized Controlled Trial
Journal Info: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Methods and operational framework of GALFLU: Individually randomized pragmatic controlled trial of high- versus standard-dose influenza vaccination in older adults.
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  Data: <searchLink fieldCode="AU" term="%22Mallah+N%22">Mallah N</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBER-ESP), Madrid, Spain; Department of Preventive Medicine and Institute of Psychology (IPISUS), University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Pardo-Seco+J%22">Pardo-Seco J</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; GenPoB Research Group, Instituto de Investigación Sanitaria (IDIS), Hospital Clínico Universitario de Santiago (SERGAS), and INCIFOR, Universidade de Santiago de Compostela (USC), 15706 Santiago de Compostela, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Rodriguez-Tenreiro-Sánchez+C%22">Rodriguez-Tenreiro-Sánchez C</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Giné-Vázquez+I%22">Giné-Vázquez I</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Mirás-Carballal+S%22">Mirás-Carballal S</searchLink>; Galician Center for Disease Control and Prevention (CEGACE). Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Piñeiro-Sotelo+M%22">Piñeiro-Sotelo M</searchLink>; Galician Center for Disease Control and Prevention (CEGACE). Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Cribeiro-González+M%22">Cribeiro-González M</searchLink>; Department of Communicable Diseases, Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Conde-Pájaro+M%22">Conde-Pájaro M</searchLink>; Dirección Xeral de Recursos Económicos, Servizo Galego de Saúde, Xunta de Galicia, Galicia, Spain.Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22González-Pérez+JM%22">González-Pérez JM</searchLink>; Subdirección de Sistemas y Tecnologías de la Información, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Razzini+JL%22">Razzini JL</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Rivero-Calle+I%22">Rivero-Calle I</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Dacosta-Urbieta+AI%22">Dacosta-Urbieta AI</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Harris+RC%22">Harris RC</searchLink>; Sanofi Vaccines, Singapore.<br /><searchLink fieldCode="AU" term="%22Loiacono+MM%22">Loiacono MM</searchLink>; Department of Epidemiology, University of Delaware, Newark, DE, USA.<br /><searchLink fieldCode="AU" term="%22van+Aalst+R%22">van Aalst R</searchLink>; Sanofi Vaccines, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Farre+JM%22">Farre JM</searchLink>; Sanofi Vaccines, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Dufournet+M%22">Dufournet M</searchLink>; Sanofi Vaccines, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Johansen+ND%22">Johansen ND</searchLink>; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Modin+D%22">Modin D</searchLink>; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Biering-Sørensen+T%22">Biering-Sørensen T</searchLink>; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Herlev, Denmark.<br /><searchLink fieldCode="AU" term="%22Duran-Parrondo+C%22">Duran-Parrondo C</searchLink>; Dirección Xeral de Saúde Pública, Consellería de Sanidade, Xunta de Galicia, Galicia, Spain.<br /><searchLink fieldCode="AU" term="%22Martinón-Torres+F%22">Martinón-Torres F</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Galicia, Spain; WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain. Electronic address: federico.martinon.torres@sergas.es.
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