Evidence map›Paper›PMID 37698366›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions.

Robert G Feldman, Raffaele Antonelli-Incalzi, Katie Steenackers, Dong-Gun Lee, Alberto Papi, Michael G Ison, Laurence Fissette, Marie-Pierre David, Céline Maréchal, Marie Van der Wielen and 3 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04886596 (A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
10.3field-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.

NCT04886596 phase3completednot on this map

A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2024Enrolled26,675ConditionsRespiratory Syncytial Virus InfectionsArmsPlacebo, RSVPreF3 OA vaccine
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Pooled it
  4. Immune persistence and safety of the AS01Human vaccines & immunotherapeutics · 2025
    Trial
  5. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  6. Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  7. Article
  8. Article
  9. AS01Drug safety · 2026
    Article
  10. Effects of positive inspiratory and expiratory pressure on diaphragmatic mobility in asymptomatic individuals: Randomised, crossover clinical trial.Hong Kong physiotherapy journal : official publication of the Hong Kong Physiotherapy Association Limited = Wu li chih liao · 2026
    Article
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  12. Review
  13. Article
  14. Review
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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

13 authors at 7 institutions in 4 countries.

Robert G FeldmanSenior Clinical Trials Inc., Laguna Hills, California, USA.
Raffaele Antonelli-IncalziDepartment of Internal Medicine and Geriatrics, Università Campus Bio-Medico di Roma, Rome, Italy.
Katie SteenackersCentre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium.
Dong-Gun LeeDivision of Infectious Diseases, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Alberto PapiPulmonary Division, University of Ferrara, St. Anna University Hospital, Ferrara, Italy.
Michael G IsonRespiratory Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.
Laurence FissetteVaccines R&D, GSK, Wavre, Belgium.
Marie-Pierre DavidVaccines R&D, GSK, Wavre, Belgium.
Céline MaréchalVaccines R&D, GSK, Wavre, Belgium.
Marie Van der WielenVaccines R&D, GSK, Wavre, Belgium.
Lusine KostanyanVaccines R&D, GSK, Wavre, Belgium.
Veronica HulstrømVaccines R&D, GSK, Wavre, Belgium.
AReSVi-006 Study Group
GlaxoSmithKline (Belgium) · BENational Institutes of Health · USThe Catholic University of Korea Seoul St. Mary's Hospital · KRLos Angeles Clinical Trials · USUniversità Campus Bio-Medico · ITUniversity of Antwerp · BEUniversity of Ferrara · IT

Funding

GlaxoSmithKline
6 · The paper itself

Abstract

backgroundOlder adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in ≥60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").

methodsMedically stable ≥60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.

resultsIn total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had ≥1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with ≥1 condition of interest (94.6%), ≥1 cardiorespiratory (92.1%), ≥1 endocrine/metabolic (100%), and ≥2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with ≥1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with ≥2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with ≥1 condition of interest as in those without.

conclusionsRSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT04886596.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedAntibodies, NeutralizingAntibodies, ViralHumansMiddle AgedAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus Vaccinescardiorespiratorycomorbidityrespiratory tract illnessRSVvaccination

Identifiers

PMID37698366
PMCPMC10810713
OpenAlexW4386623915

What OpenQuestion holds

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LicenceCC BY
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.