Evidence map›Paper›PMID 34714720›Full record

Trial reportHuman vaccines & immunotherapeutics2021

Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial.

Stephanie Pepin, Jean-François Nicolas, Henryk Szymanski, Isabel Leroux-Roels, Thomas Schaum, Marc Bonten, Giancarlo Icardi, Anju Shrestha, Cynthia Tabar, QHD00011 study team

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
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  6. Influenza vaccination in older people: a geriatrician's perspective.Aging clinical and experimental research · 2025
    Review
  7. Journal of preventive medicine and hygiene · 2025
    Article
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  10. Review
  11. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 7 countries.

Stephanie PepinGlobal Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.
Jean-François NicolasClinical Immunology & Allergology Department, Centre Hospitalier Lyon-Sud, Lyon, France.
Henryk SzymanskiPaediatrics, St Hedwig of Silesia Hospital Trzebnica, Prusicka, Trzebnica, Poland.
Isabel Leroux-RoelsCentrum Voor Vaccinologie, Ghent University Hospital, Ghent, Belgium.
Thomas SchaumRED-Institut, Oldenburg in Holstein, Germany.
Marc BontenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Giancarlo IcardiDepartment of Health Sciences, Ospedale Policlinico S. Martino IRCCS, University of Genoa, Genoa, Italy.ORCID 0000-0002-8463-8487
Anju ShresthaGlobal Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA, USA.
Cynthia TabarGlobal Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.
QHD00011 study team
Sanofi (France) · FRGhent University Hospital · BEHôpital Lyon Sud · FROspedale Policlinico San Martino · ITRed Hat (United States) · USSanofi (United States) · USSt. Hedwig-Krankenhaus · DEUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60-64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28 d post vaccination in participants aged 60-64 and ≥65 y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60-64 y and those aged ≥65 y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60-64 y than those aged ≥65 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants ≥60 y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged ≥60 y, as was previously assessed for adults aged ≥65 y.

Indexed as

Influenza, HumanInfluenza VaccinesAdultAntibodies, ViralDouble-Blind MethodHemagglutination Inhibition TestsHumansImmunogenicity, VaccineVaccines, CombinedVaccines, InactivatedAntibodies, ViralInfluenza VaccinesVaccines, CombinedVaccines, InactivatedHigh-dose influenza vaccineimmunogenicityinfluenza vaccinationolder adultsPhase III trialsafety

Identifiers

PMID34714720
PMCPMC8903946
OpenAlexW3210045060

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.