A Pragmatic Randomized Feasibility Trial of Influenza Vaccines

Niklas Dyrby Johansen; Daniel Modin; Joshua Nealon; Sandrine Samson; Camille Salamand; Matthew M Loiacono; Carsten Schade Larsen; Anne Marie Reimer Jensen; Nino Emanuel Landler; Brian L Claggett; Scott D Solomon; Martin J Landray; Gunnar H Gislason; Lars Køber; Jens Ulrik Stæhr Jensen; Pradeesh Sivapalan; Lasse Skafte Vestergaard; Palle Valentiner-Branth; Tyra Grove Krause; Tor Biering-Sørensen

doi:10.1056/EVIDoa2200206

A Pragmatic Randomized Feasibility Trial of Influenza Vaccines

NEJM Evid. 2023 Feb;2(2):EVIDoa2200206. doi: 10.1056/EVIDoa2200206. Epub 2023 Jan 23.

Authors

Niklas Dyrby Johansen^{1

2}, Daniel Modin^{1

2}, Joshua Nealon³, Sandrine Samson⁴, Camille Salamand⁴, Matthew M Loiacono⁵, Carsten Schade Larsen⁶, Anne Marie Reimer Jensen^{1

2}, Nino Emanuel Landler^{1

2}, Brian L Claggett⁷, Scott D Solomon⁷, Martin J Landray^{8

9}, Gunnar H Gislason^{1

10

11

12}, Lars Køber^{10

13}, Jens Ulrik Stæhr Jensen¹⁴, Pradeesh Sivapalan¹⁴, Lasse Skafte Vestergaard¹⁵, Palle Valentiner-Branth¹⁵, Tyra Grove Krause¹⁵, Tor Biering-Sørensen^{1

2}

Affiliations

¹ Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen.
² Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen.
³ School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.
⁴ Sanofi, Lyon, France.
⁵ Sanofi, Swiftwater, PA.
⁶ Department of Clinical Medicine, Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
⁷ Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston.
⁸ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Public Health, University of Oxford, Oxford, United Kingdom.
⁹ Big Data Institute, University of Oxford, Oxford, United Kingdom.
¹⁰ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen.
¹¹ The Danish Heart Foundation, Copenhagen.
¹² The National Institute of Public Health, University of Southern Denmark, Copenhagen.
¹³ Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen.
¹⁴ Respiratory Medicine Section, Department of Medicine, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen.
¹⁵ Epidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen.

PMID: 38320035
DOI: 10.1056/EVIDoa2200206

Abstract

Randomized Feasibility Trial of Influenza VaccinesThis pragmatic, open-label, active-controlled, randomized feasibility trial of QIV-HD versus QIV-SD was conducted in Danish citizens aged 65 to 79 years during the 2021-2022 influenza season. Randomization was integrated into routine vaccination practice. Only nationwide administrative health registries were used for data collection.

Publication types

Randomized Controlled Trial

MeSH terms

Antibodies, Viral
Feasibility Studies
Hemagglutination Inhibition Tests
Humans
Influenza Vaccines*
Influenza, Human*
Vaccines, Inactivated

Substances

Influenza Vaccines
Antibodies, Viral
Vaccines, Inactivated