Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial
Abstract Background High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to stand...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01044-w |
| _version_ | 1828414903192387584 |
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| author | Niklas Dyrby Johansen Daniel Modin Joshua Nealon Sandrine Samson Camille Salamand Carsten Schade Larsen 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 |
| author_facet | Niklas Dyrby Johansen Daniel Modin Joshua Nealon Sandrine Samson Camille Salamand Carsten Schade Larsen 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 |
| author_sort | Niklas Dyrby Johansen |
| collection | DOAJ |
| description | Abstract Background High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to standard-dose vaccines on hospitalizations and mortality would enable more robust public health and cost-effectiveness estimates. This study aims to investigate the feasibility of conducting a pragmatic randomized clinical trial in Denmark comparing high-dose to standard-dose vaccines utilizing existing vaccination infrastructure and the Danish nationwide health registries for data collection. Methods The DANFLU-1 trial (NCT05048589) is a pragmatic, open-label, active-controlled randomized trial randomizing Danish citizens aged 65–79 years to either high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine. The study utilizes the infrastructure of a private vaccination provider (Danske Lægers Vaccinations Service) for recruitment, inclusion, randomization, and vaccination. All collection of baseline and follow-up data including safety monitoring is performed centrally by the Department of Cardiology at Herlev and Gentofte Hospital, Copenhagen, Denmark using the Danish nationwide health registries. The study aims to include 40,000 participants during the 2021/2022 influenza season. The primary endpoints address feasibility and include the number of participants enrolled, randomization balance, and representativeness compared to the Danish general population. Relative vaccine effectiveness will also be assessed, however, this feasibility study is not powered for clinical outcomes and may be affected by the COVID-19 pandemic. Discussion The DANFLU-1 study is investigating the feasibility of conducting a large-scale pragmatic clinical trial in Denmark utilizing existing infrastructure and the Danish nationwide registries. This will provide valuable insight, especially for potential future fully powered vaccine trials, but also for trials wishing to investigate other interventions. Trial registration Clinicaltrials.gov : NCT05048589 , registered September 17, 2021. |
| first_indexed | 2024-12-10T13:35:02Z |
| format | Article |
| id | doaj.art-ac4b6ad6a252401fb44f9392c2ffb4df |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-10T13:35:02Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-ac4b6ad6a252401fb44f9392c2ffb4df2022-12-22T01:46:51ZengBMCPilot and Feasibility Studies2055-57842022-04-018111110.1186/s40814-022-01044-wFeasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 TrialNiklas Dyrby Johansen0Daniel Modin1Joshua Nealon2Sandrine Samson3Camille Salamand4Carsten Schade Larsen5Brian L. Claggett6Scott D. Solomon7Martin J. Landray8Gunnar H. Gislason9Lars Køber10Jens Ulrik Stæhr Jensen11Pradeesh Sivapalan12Lasse Skafte Vestergaard13Palle Valentiner-Branth14Tyra Grove Krause15Tor Biering-Sørensen16Department of Cardiology, Copenhagen University Hospital - Herlev and GentofteDepartment of Cardiology, Copenhagen University Hospital - Herlev and GentofteInfluenza Medical Evidence Generation, Sanofi PasteurGlobal Medical Affairs, Sanofi PasteurClinical Department, Biostatistical SciencesDepartment of Clinical Medicine – Department of Infectious Diseases, Aarhus University HospitalCardiovascular Division, Brigham and Women’s Hospital, Harvard Medical SchoolCardiovascular Division, Brigham and Women’s Hospital, Harvard Medical SchoolClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Public Health, University of OxfordDepartment of Cardiology, Copenhagen University Hospital - Herlev and GentofteDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of CopenhagenRespiratory Medicine Section, Department of Medicine, Copenhagen University Hospital – Herlev and GentofteRespiratory Medicine Section, Department of Medicine, Copenhagen University Hospital – Herlev and GentofteDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum InstitutDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum InstitutDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum InstitutDepartment of Cardiology, Copenhagen University Hospital - Herlev and GentofteAbstract Background High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to standard-dose vaccines on hospitalizations and mortality would enable more robust public health and cost-effectiveness estimates. This study aims to investigate the feasibility of conducting a pragmatic randomized clinical trial in Denmark comparing high-dose to standard-dose vaccines utilizing existing vaccination infrastructure and the Danish nationwide health registries for data collection. Methods The DANFLU-1 trial (NCT05048589) is a pragmatic, open-label, active-controlled randomized trial randomizing Danish citizens aged 65–79 years to either high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine. The study utilizes the infrastructure of a private vaccination provider (Danske Lægers Vaccinations Service) for recruitment, inclusion, randomization, and vaccination. All collection of baseline and follow-up data including safety monitoring is performed centrally by the Department of Cardiology at Herlev and Gentofte Hospital, Copenhagen, Denmark using the Danish nationwide health registries. The study aims to include 40,000 participants during the 2021/2022 influenza season. The primary endpoints address feasibility and include the number of participants enrolled, randomization balance, and representativeness compared to the Danish general population. Relative vaccine effectiveness will also be assessed, however, this feasibility study is not powered for clinical outcomes and may be affected by the COVID-19 pandemic. Discussion The DANFLU-1 study is investigating the feasibility of conducting a large-scale pragmatic clinical trial in Denmark utilizing existing infrastructure and the Danish nationwide registries. This will provide valuable insight, especially for potential future fully powered vaccine trials, but also for trials wishing to investigate other interventions. Trial registration Clinicaltrials.gov : NCT05048589 , registered September 17, 2021.https://doi.org/10.1186/s40814-022-01044-wRandomized controlled trialPragmaticInfluenzaVaccineRegistryFeasibility |
| spellingShingle | Niklas Dyrby Johansen Daniel Modin Joshua Nealon Sandrine Samson Camille Salamand Carsten Schade Larsen 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 Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial Pilot and Feasibility Studies Randomized controlled trial Pragmatic Influenza Vaccine Registry Feasibility |
| title | Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial |
| title_full | Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial |
| title_fullStr | Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial |
| title_full_unstemmed | Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial |
| title_short | Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial |
| title_sort | feasibility of randomizing danish citizens aged 65 79 years to high dose quadrivalent influenza vaccine vs standard dose quadrivalent influenza vaccine in a pragmatic registry based setting rationale and design of the danflu 1 trial |
| topic | Randomized controlled trial Pragmatic Influenza Vaccine Registry Feasibility |
| url | https://doi.org/10.1186/s40814-022-01044-w |
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