Evidence map›Paper›PMID 37393237›Full record

ArticleImmunity & ageing : I & A2023

Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial.

Kenneth E Schmader, Christine K Liu, Brendan Flannery, Wes Rountree, Heidi Auerbach, Elizabeth D Barnett, Elizabeth P Schlaudecker, Christopher A Todd, Marek Poniewierski, Mary A Staat and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Immunity & ageing : I & A, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03183908 (Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03183908 phase4completednot on this map

Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults

TypeinterventionalSponsorDuke UniversityRan2017 to 2019Enrolled757ConditionsPain, Quality of Life, Injection Site Reaction, Side Effect of DrugArmsFLUAD®, Fluzone® High-Dose
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
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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

14 authors.

Kenneth E SchmaderDivision of Geriatrics, Department of Medicine and Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA. kenneth.schmader@duke.edu.
Christine K LiuSection of Geriatrics, Division of Primary Care and Population Health, Stanford University, Stanford, CA, USA.
Brendan FlanneryInfuenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Wes RountreeDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Heidi AuerbachGeriatrics Section, Department of Medicine, School of Medicine and Boston Medical Center, Boston University, Chobanian & Avedisian, Boston, MA, USA.
Elizabeth D BarnettDepartment of Pediatrics, Section of Pediatric Infectious Diseases, School of Medicine and Boston Medical Center, Boston University, Chobanian & Avedisian, Boston, MD, USA.
Elizabeth P SchlaudeckerDepartment of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine and Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
Christopher A ToddDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Marek PoniewierskiDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Mary A StaatDepartment of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine and Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
Theresa HarringtonImmunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Rongxia LiImmunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Karen R BroderImmunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Emmanuel B WalterDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.

resultsThe immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, - 5.8%; 95%CI, - 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.

conclusionsOverall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.

trial registrationClinicalTrials.gov Identifier: NCT03183908.

Indexed as

Adjuvanted influenza vaccineAgedHigh dose influenza vaccineImmunogenicityInfluenza vaccine

Identifiers

PMID37393237
PMCPMC10314373

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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.