Evidence map›Paper›PMID 26908801›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults.

Carlos A DiazGranados, Andrew J Dunning, Corwin A Robertson, H Keipp Talbot, Victoria Landolfi, David P Greenberg

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03599739 (Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 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.

NCT03599739 completednot on this mapstarted 2018, after this paper: background citation

Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year

TypeobservationalSponsorInsight Therapeutics, LLCRan2018 to 2023Enrolled598ConditionsInfluenza, Influenza-like Illness, Influenza, HumanArmsInfluenza
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. [High-dose trivalent influenza vaccine: safety and immunogenicity].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2021
    Pooled it
  3. Preliminary Findings From the Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures (DRIVE I) Study: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. [High-dose trivalent influenza vaccine. Efficacy and effectiveness].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2020
    Review
  12. Influence of immune aging on vaccine responses.The Journal of allergy and clinical immunology · 2020
    Review
  13. Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccine Among Patients Receiving Maintenance Hemodialysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2020
    Article
  14. Article
  15. Article
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Carlos A DiazGranadosSanofi Pasteur, Swiftwater, Pennsylvania.
Andrew J DunningSanofi Pasteur, Swiftwater, Pennsylvania.
Corwin A RobertsonSanofi Pasteur, Swiftwater, Pennsylvania.
H Keipp TalbotVanderbilt University Medical Center, Nashville, Tennessee.
Victoria LandolfiSanofi Pasteur, Swiftwater, Pennsylvania.
David P GreenbergSanofi Pasteur, Swiftwater, Pennsylvania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh-dose inactivated influenza vaccine (IIV-HD) is an alternative to the standard-dose inactivated influenza vaccine (IIV-SD) in the United States for influenza prevention in older adults. IIV-HD improved efficacy relative to IIV-SD in a randomized controlled trial. Recent observational studies suggest that previous influenza vaccination may influence the immunogenicity and effectiveness of current-season vaccination.

methodsThe original study was a double-blind, randomized trial comparing IIV-HD to IIV-SD in adults aged ≥65 years over 2 influenza seasons. A subset of year 1 (Y1) participants reenrolled in year 2 (Y2), receiving vaccine by random assignment in both years. We evaluated the effect of Y1 vaccination on Y2 relative vaccine efficacy (VE), immunogenicity (hemagglutination inhibition [HAI] titers), and safety among reenrolled participants.

resultsOf 14 500 Y1 participants, 7643 reenrolled in Y2. Relative to participants who received IIV-SD both seasons, VE was higher for IIV-HD vaccinees in Y2 (28.3% overall; 25.1% for Y1 IIV-HD, Y2 IIV-HD; and 31.6% for Y1 IIV-SD, Y2 IIV-HD). In multivariate logistic regression models, Y1 vaccine was not a significant modifier of Y2 VE (P= .43), whereas Y2 IIV-HD remained significantly associated with lower influenza risk (P= .043). Compared to administration of IIV-SD in both years, postvaccination HAI titers were significantly higher for patterns that included IIV-HD in Y2. No safety concerns were raised with IIV-HD revaccination.

conclusionsIIV-HD is likely to provide clinical benefit over IIV-SD irrespective of previous-season vaccination with IIV-HD or IIV-SD. IIV-HD consistently improved immune responses, and no safety concerns emerged in the context of IIV-HD revaccination.

Indexed as

AgedAged, 80 and overDouble-Blind MethodFemaleHemagglutination Inhibition TestsHumansImmunization, SecondaryImmunogenicity, VaccineInfluenza, HumanInfluenza VaccinesMaleTreatment OutcomeUnited StatesInfluenza Vaccinesage 80 and olderagedhuman influenza vaccinesinactivated vaccinesphase 3 clinical trial

Identifiers

PMID26908801
PMCPMC4826458

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.