A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update.

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Title: A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update.
Authors: Lassen MCH; 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, Copenhagen, Denmark., Christensen SH; 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, Copenhagen, Denmark., 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, Copenhagen, Denmark., Yafasov M; 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, Copenhagen, Denmark., Pareek M; 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, Copenhagen, Denmark., Rudolph AE; Pfizer, New York, NY., Tenreiro-Sánchez CR; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago de Compostela (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., Skaarup KG; 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, 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, Copenhagen, Denmark., Claggett BL; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA., Larsen CS; Department of Clinical Medicine-Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark., Larsen L; Research Unit for Infectious Diseases, Odense University Hospital, Odense, Denmark., Wiese L; Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark., Dalager-Pedersen M; Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark., Lindholm MG; Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark., Køber L; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark., Solomon SD; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA., Jensen JUS; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Respiratory Medicine Section, Department of Medicine, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark., Martel CJ; Epidemiological Infectious Disease Preparedness, Statens Serum Institute, Copenhagen, Denmark., Aliabadi N; Pfizer, New York, NY., Schwarz C; Pfizer, New York, NY., Skovdal M; Pfizer, New York, NY., Zhang P; Pfizer, New York, NY., López-Gómez V; Pfizer, New York, NY., Welsh S; Pfizer, New York, NY., Gessner BD; Pfizer, New York, NY., Martinón-Torres F; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago de Compostela (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., Begier E; Pfizer, New York, NY., 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, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Copenhagen, Denmark. Electronic address: tor.biering@gmail.com.
Source: American heart journal [Am Heart J] 2026 Oct; Vol. 300, pp. 107497. Date of Electronic Publication: 2026 Jun 01.
Publication Type: Journal Article; Pragmatic Clinical Trial; Randomized Controlled Trial
Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update.
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  Data: <searchLink fieldCode="AU" term="%22Lassen+MCH%22">Lassen MCH</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, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Christensen+SH%22">Christensen SH</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, Copenhagen, Denmark.<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, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Yafasov+M%22">Yafasov M</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, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Pareek+M%22">Pareek M</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, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Rudolph+AE%22">Rudolph AE</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Tenreiro-Sánchez+CR%22">Tenreiro-Sánchez CR</searchLink>; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago de Compostela (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="%22Skaarup+KG%22">Skaarup KG</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, 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, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Claggett+BL%22">Claggett BL</searchLink>; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.<br /><searchLink fieldCode="AU" term="%22Larsen+CS%22">Larsen CS</searchLink>; Department of Clinical Medicine-Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Larsen+L%22">Larsen L</searchLink>; Research Unit for Infectious Diseases, Odense University Hospital, Odense, Denmark.<br /><searchLink fieldCode="AU" term="%22Wiese+L%22">Wiese L</searchLink>; Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.<br /><searchLink fieldCode="AU" term="%22Dalager-Pedersen+M%22">Dalager-Pedersen M</searchLink>; Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Lindholm+MG%22">Lindholm MG</searchLink>; Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark.<br /><searchLink fieldCode="AU" term="%22Køber+L%22">Køber L</searchLink>; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Solomon+SD%22">Solomon SD</searchLink>; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.<br /><searchLink fieldCode="AU" term="%22Jensen+JUS%22">Jensen JUS</searchLink>; Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Respiratory Medicine Section, Department of Medicine, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Martel+CJ%22">Martel CJ</searchLink>; Epidemiological Infectious Disease Preparedness, Statens Serum Institute, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Aliabadi+N%22">Aliabadi N</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Schwarz+C%22">Schwarz C</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Skovdal+M%22">Skovdal M</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Zhang+P%22">Zhang P</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22López-Gómez+V%22">López-Gómez V</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Welsh+S%22">Welsh S</searchLink>; Pfizer, New York, NY.<br /><searchLink fieldCode="AU" term="%22Gessner+BD%22">Gessner BD</searchLink>; Pfizer, New York, NY.<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 de Compostela (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="%22Begier+E%22">Begier E</searchLink>; Pfizer, New York, NY.<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, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Copenhagen, Denmark. Electronic address: tor.biering@gmail.com.
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  Data: <searchLink fieldCode="JN" term="%220370465%22">American heart journal</searchLink> [Am Heart J] 2026 Oct; Vol. 300, pp. 107497. <i>Date of Electronic Publication: </i>2026 Jun 01.
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