Evidence map›Paper›PMID 40884413›Full record

Trial reportEuropean heart journal2025

High-dose vs. standard-dose inactivated influenza vaccine and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease: the DANFLU-2 trial.

Manan Pareek, Niklas Dyrby Johansen, Daniel Modin, Matthew M Loiacono, Rebecca C Harris, Marine Dufournet, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen and 27 more

Abstract readRandomized Controlled TrialComparative StudyMulticenter Study
In one paragraph

Trial report in European heart journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors.

Manan PareekDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0002-0867-5825
Niklas Dyrby JohansenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Daniel ModinDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0002-7566-0519
Matthew M LoiaconoSanofi, Swiftwater, PA, USA.
Rebecca C HarrisSanofi, Singapore.ORCID 0000-0002-2636-1520
Marine DufournetSanofi, Lyon, France.
Carsten Schade LarsenDepartment of Clinical Medicine and Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Lykke LarsenDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-4113-4182
Lothar WieseDepartment of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0003-2719-1743
Michael Dalager-PedersenDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
Brian L ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Kira Hyldekær JanstrupDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Katja Vu BartholdyDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Katrine Feldballe BernholmDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Julie Inge-Marie Helene BorchseniusDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Filip Søskov DavidovskiDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Lise Witten DavodianDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Maria DonsDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Lisa Steen DuusDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Caroline EspersenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0003-2879-8862
Frederik Holme FussingDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Anne Marie Reimer JensenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Nino Emanuel LandlerDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Adam Cadovius Femerling LanghoffDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Mats Christian Højbjerg LassenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Anne Bjerg NielsenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Camilla Ikast OttosenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Morten SengeløvDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Kristoffer Grundtvig SkaarupDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Martin J LandrayNuffield Department of Population Health, University of Oxford, Oxford, UK.
Gunnar H GislasonDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Lars KøberFaculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6635-1466
Pradeesh SivapalanFaculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-8620-3655
Cyril Jean-Marie MartelEpidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen, Denmark.
Jens Ulrik Stæhr JensenFaculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Tor Biering-SørensenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0003-4209-2778

Funding

Sanofi
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe aim was to evaluate and compare the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) vs. standard-dose inactivated influenza vaccination (SD-IIV) on respiratory and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease (ASCVD).

methodsA prespecified exploratory analysis of a pragmatic, open-label, individually randomized trial conducted in Denmark during three influenza seasons. Adults ≥65 years were randomized 1:1 to HD-IIV or SD-IIV. Baseline and outcome data were collected through nationwide registries. The primary outcome was hospitalization for influenza or pneumonia. Major adverse cardiovascular events (MACE) was defined as a composite of cardiovascular death, hospitalization for myocardial infarction, or hospitalization for stroke. Heterogeneity in rVE among participants with vs. without ASCVD was assessed.

resultsThe incidence of all outcomes was higher in participants with pre-existing ASCVD (n = 46 825) vs. those without (n = 285 613). rVE was consistent among participants with and without ASCVD (all Pinteraction ≥ .05). The rVE for the primary outcome was 6.87% [95% confidence interval (CI), -2.52 to 15.42] among individuals without ASCVD and 4.71% (95% CI, -11.58 to 18.63) in those with (Pinteraction = .80). For influenza hospitalizations, the rVE was 42.88% (95% CI, 22.07-58.44) vs. 45.73% (95% CI, 16.68-65.16) in those without vs. with ASCVD (Pinteraction = .84). For MACE, the rVE was 4.29% (95% CI, -6.50 to 14.00) in participants without, and 0.30% (95% CI, -17.56 to 15.44) in participants with, pre-existing ASCVD (Pinteraction = .68).

conclusionsAmong individuals ≥65 years, the rVE of HD-IIV vs. SD-IIV against respiratory and cardiovascular outcomes was similar among those with vs. without pre-existing ASCVD.

Indexed as

AtherosclerosisCardiovascular DiseasesInfluenza, HumanInfluenza VaccinesAgedAged, 80 and overDenmarkFemaleHospitalizationHumansMaleVaccine EfficacyVaccines, InactivatedInfluenza VaccinesVaccines, InactivatedAtherosclerosisCardiovascular diseasesInfluenzaRandomized controlled trialRegistriesVaccination

Identifiers

PMID40884413
PMCPMC12579978

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.