Evidence map›Paper›PMID 25119609›Full record

Trial reportThe New England journal of medicine2014

Efficacy of high-dose versus standard-dose influenza vaccine in older adults.

Carlos A DiazGranados, Andrew J Dunning, Murray Kimmel, Daniel Kirby, John Treanor, Avi Collins, Richard Pollak, Janet Christoff, John Earl, Victoria Landolfi and 7 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIClinical Trial, Phase IVComparative Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 443 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
443citing papers in PubMed, 10 pooled it
39.0field-weighted citation impact, top 1% of its field
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.

NCT01427309 phase4completednot on this map

Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2013Enrolled31,989ConditionsInfluenzaArmsHigh Dose Trivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine
NCT01815268 phase4unknown statusnot on this map

High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

TypeinterventionalSponsorInsight Therapeutics, LLCRan2013 to 2018Enrolled823ConditionsInfluenzaArmsHD Vaccine, SD Vaccine, Free Vaccine, Usual Care
NCT03694808 phase4completednot on this mapstarted 2018, after this paper: background citation

Non-inferiority Study of Adjuvanted vs. High Dose Flu Vaccine in Residents of Long Term Care

TypeinterventionalSponsorDavid H. CanadayRan2018 to 2023Enrolled478ConditionsFluArmsFluad Vaccine, Fluzone HD Vaccine
3 · Its place in the literature

Who cites it

443 citing papers in PubMed, 10 syntheses or guidelines pooled it, 843 citations in OpenAlex.

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  8. Vaccination of Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
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  12. Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to Charlson Comorbidity Index: A post-hoc analysis of the DANFLU-1 randomized trial.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
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  16. A Bayesian re-analysis of the DANFLU-1 trial.Human vaccines & immunotherapeutics · 2025
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383 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 1 country.

Carlos A DiazGranadosFrom Sanofi Pasteur, Swiftwater (C.A.D., A.J.D., D.K., J.C., V.L., S.G., D.P.G., N.G.T., M.D.D.), ReSearch Pharmaceutical Services, Fort Washington (A.C.), and the Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh (D.P.G.) - all in Pennsylvania; Accelovance, Melbourne, FL (M.K.); University of Rochester, Rochester, NY (J.T.); Endeavor Clinical Trials, San Antonio (R.P.), and Martin Diagnostic Clinic, Tomball (E.M.) - both in Texas; PMG Research of Hickory, Hickory, NC (J.E.); Idaho Falls Infectious Diseases and Snake River Research, Idaho Falls, ID (R.N.); and the Department of Health Policy, Vanderbilt University School of Medicine (M.D.D.) and Vanderbilt University Medical Center (H.K.T.) - both in Nashville.
Andrew J Dunning
Murray Kimmel
Daniel Kirby
John Treanor
Avi Collins
Richard Pollak
Janet Christoff
John Earl
Victoria Landolfi
Earl Martin
Sanjay Gurunathan
Richard Nathan
David P Greenberg
Nadia G Tornieporth
Michael D Decker
H Keipp Talbot
Sanofi (United States) · USAccelovance (United States) · USClinical Trials of Texas · USMartin Diagnostic Clinic · USPMG Research · USUniversity of Pittsburgh · USUniversity of Rochester · USVanderbilt University · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs compared with a standard-dose vaccine, a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) improves antibody responses to influenza among adults 65 years of age or older. This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness.

methodsWe conducted a phase IIIb-IV, multicenter, randomized, double-blind, active-controlled trial to compare IIV3-HD (60 μg of hemagglutinin per strain) with standard-dose trivalent, inactivated influenza vaccine (IIV3-SD [15 μg of hemagglutinin per strain]) in adults 65 years of age or older. Assessments of relative efficacy, effectiveness, safety (serious adverse events), and immunogenicity (hemagglutination-inhibition [HAI] titers) were performed during the 2011-2012 (year 1) and the 2012-2013 (year 2) northern-hemisphere influenza seasons.

resultsA total of 31,989 participants were enrolled from 126 research centers in the United States and Canada (15,991 were randomly assigned to receive IIV3-HD, and 15,998 to receive IIV3-SD). In the intention-to-treat analysis, 228 participants in the IIV3-HD group (1.4%) and 301 participants in the IIV3-SD group (1.9%) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness (relative efficacy, 24.2%; 95% confidence interval [CI], 9.7 to 36.5). At least one serious adverse event during the safety surveillance period was reported by 1323 (8.3%) of the participants in the IIV3-HD group, as compared with 1442 (9.0%) of the participants in the IIV3-SD group (relative risk, 0.92; 95% CI, 0.85 to 0.99). After vaccination, HAI titers and seroprotection rates (the percentage of participants with HAI titers ≥ 1:40) were significantly higher in the IIV3-HD group. Conclusions: Among persons 65 years of age or older, IIV3-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3-SD. (Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01427309.).

Indexed as

AgedAntibodies, ViralChronic DiseaseDouble-Blind MethodFemaleHumansInfluenza, HumanInfluenza VaccinesIntention to Treat AnalysisMaleOrthomyxoviridaeVaccines, InactivatedAntibodies, ViralInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID25119609
OpenAlexW2168805652

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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 OpenQuestion graph.