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
NCT ID: NCT05048589
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
12551 participants
INTERVENTIONAL
2021-10-01
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
NCT05517174
Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
NCT06506812
A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
NCT02553343
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
NCT04024228
Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
NCT04137887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The findings of this pilot trial will indicate whether the conduction of a full-scale, adequately powered pragmatic RCT is feasible within the Danish registry-based framework.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard-Dose Quadrivalent Influenza Vaccine
QIV-SD single injection at Day 0
Standard-Dose Quadrivalent Influenza Vaccine
For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.
High-Dose Quadrivalent Influenza Vaccine
QIV-HD single injection at Day 0
High-Dose Quadrivalent Influenza Vaccine
For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard-Dose Quadrivalent Influenza Vaccine
For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.
High-Dose Quadrivalent Influenza Vaccine
For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Informed consent form has been signed and dated
Exclusion Criteria
65 Years
79 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Tor Biering-Sørensen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tor Biering-Sørensen
Research Director, MD, PhD, MPH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tor Biering-Sørensen, MD, PhD, MPH
Role: STUDY_CHAIR
Research Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
Hellerup, , Denmark
Danske Lægers Vaccinations Service
Søborg, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Christensen J, Johansen ND, Janstrup KH, Modin D, Skaarup KG, Nealon J, Samson S, Loiacono M, Harris R, Larsen CS, Jensen AMR, Landler NE, Claggett BL, Solomon SD, Gislason GH, Kober L, Landray MJ, Sivapalan P, Jensen JUS, Biering-Sorensen T. Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: A post hoc analysis of the DANFLU-1 randomized clinical trial. J Infect. 2024 Nov;89(5):106276. doi: 10.1016/j.jinf.2024.106276. Epub 2024 Sep 18.
Christensen J, Johansen ND, Modin D, Janstrup KH, Nealon J, Samson S, Loiacono M, Harris R, Larsen CS, Jensen AMR, Landler NE, Claggett BL, Solomon SD, Gislason GH, Kober L, Landray MJ, Sivapalan P, Jensen JUS, Biering-Sorensen T. Relative Effectiveness of High-Dose Versus Standard-Dose Quadrivalent Influenza Vaccine in Older Adults With Cardiovascular Disease: A Prespecified Analysis of the DANFLU-1 Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011496. doi: 10.1161/CIRCOUTCOMES.124.011496. Epub 2024 Aug 31.
Johansen ND, Modin D, Nealon J, Samson S, Salamand C, Loiacono MM, Larsen CS, Jensen AMR, Landler NE, Claggett BL, Solomon SD, Landray MJ, Gislason GH, Kober L, Jensen JUS, Sivapalan P, Vestergaard LS, Valentiner-Branth P, Krause TG, Biering-Sorensen T. A Pragmatic Randomized Feasibility Trial of Influenza Vaccines. NEJM Evid. 2023 Feb;2(2):EVIDoa2200206. doi: 10.1056/EVIDoa2200206. Epub 2023 Jan 23.
Johansen ND, Modin D, Skaarup KG, Nealon J, Samson S, Dufournet M, Loiacono MM, Harris RC, Larsen CS, Jensen AMR, Landler NE, Claggett BL, Solomon SD, Landray MJ, Gislason GH, Kober L, Jensen JUS, Sivapalan P, Vestergaard LS, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Effectiveness of high-dose versus standard-dose quadrivalent influenza vaccine against recurrent hospitalizations and mortality in relation to influenza circulation: A post-hoc analysis of the DANFLU-1 randomized clinical trial. Clin Microbiol Infect. 2024 Nov;30(11):1453-1459. doi: 10.1016/j.cmi.2024.01.017. Epub 2024 Jan 28.
Johansen ND, Modin D, Nealon J, Samson S, Salamand C, Larsen CS, Claggett BL, Solomon SD, Landray MJ, Gislason GH, Kober L, Jensen JUS, Sivapalan P, Vestergaard LS, Valentiner-Branth P, Krause TG, Biering-Sorensen T. 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 Feasibility Stud. 2022 Apr 21;8(1):87. doi: 10.1186/s40814-022-01044-w.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QHD00027
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003170-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DANFLU-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.