Evidence map›Paper›PMID 19508159›Full record

Trial reportThe Journal of infectious diseases2009

Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older.

Ann R Falsey, John J Treanor, Nadia Tornieporth, Jose Capellan, Geoffrey J Gorse

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2009. 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 179 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
179citing papers in PubMed, 7 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.

NCT00391053 phase3completednot on this map

Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2006 to 2008Enrolled3,851ConditionsOrthomyxoviridae Infection, Influenza, Myxovirus InfectionArmsHigh-Dose Inactivated, Split-Virion Influenza Vaccine, Inactivated, Split-Virion Influenza Vaccine
NCT01815268 phase4unknown statusnot on this mapstarted 2013, after this paper: background citation

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

179 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  4. [High-dose trivalent influenza vaccine: safety and immunogenicity].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2021
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  5. Guideline
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  8. 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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119 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Ann R FalseyDepartment of Medicine, Rochester General Hospital, Rochester, NY, USA. ann.falsey@viahealth.org
John J Treanor
Nadia Tornieporth
Jose Capellan
Geoffrey J Gorse

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfluenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed.

methodsA multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults > or = 65 years of age.

resultsHD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate.

conclusionsThere was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.

trial registrationClinicalTrials.gov identifier: NCT00391053 .

Indexed as

AgedAged, 80 and overAntibodies, ViralDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHumansInfluenza, HumanInfluenza VaccinesMaleAntibodies, ViralInfluenza Vaccines

Identifiers

PMID19508159

What OpenQuestion holds

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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.