Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons.
Trial report 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 100 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
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
Who cites it
100 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Safety and Efficacy of Respiratory Syncytial Virus Vaccination in Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials.JMIR public health and surveillance · 2025Pooled it
- Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy of anti-RSV vaccination in preventing respiratory syncytial virus disease and severe illness in older adults: a systematic review of randomized controlled trials.European geriatric medicine · 2024Pooled it
- A first-in-human Phase 1/1b randomized trial evaluating the safety and immunogenicity of a respiratory syncytial virus (RSV) virus-like particle subunit vaccine (IVX-121) in healthy young and older adults.Human vaccines & immunotherapeutics · 2026Trial
- Trial
- Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged ≥60 Years.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Immunogenicity and safety of a single dose of adjuvanted RSVPreF3 vaccine in adults ≥60 years of age in China: results from a phase 3 immunobridging trial.Frontiers in immunology · 2026Trial
- Immune persistence and safety of the AS01Human vaccines & immunotherapeutics · 2025Trial
- Simultaneous vaccination against influenza and respiratory syncytial virus in high-risk heart failure patients.ESC heart failure · 2025Trial
- Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- 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 · 2024Trial
- Twenty-five years of human metapneumovirus research.Clinical microbiology reviews · 2026Review
- Article
- Review
- Hospital Admissions for Respiratory Syncytial Virus (RSV) Among Elderly: A Retrospective Study From an Italian Southern Region During Years 2018-2023.Influenza and other respiratory viruses · 2026Article
- Adjuvanted RSVPreF3 vaccine impact over three respiratory syncytial virus seasons in older adults with comorbidities.ERJ open research · 2026Article
- Cost-effectiveness of a single dose of the adjuvanted respiratory syncytial virus preFusion protein 3 vaccine over 5 years and its potential public health impact among older adults in Italy.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- Bivalent RSVpreF effectiveness against RSV-associated hospital or emergency department care over two seasons: a retrospective test-negative case control study.Lancet regional health. Americas · 2026Article
- AS01Drug safety · 2026Article
- Delineating RSV-A and RSV-B: Epidemiological Patterns, Diagnostics, Clinical Severity, and Preventive Approaches.Journal of medical virology · 2026Review
40 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
backgroundThe adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post-dose 1.
methodsIn this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre-season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre-season 2; participants who received placebo pre-season 1 received placebo pre-season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion: lower limits of 2-sided CIs around efficacy estimates >20%).
resultsThe efficacy analysis comprised 24 967 participants (RSV_1dose: 6227; RSV_revaccination: 6242; placebo: 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2-80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6-92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI: 48.1-80.0%) against RSV-LRTD and 78.8% (95% CI: 52.5-92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1.
conclusionsOne RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post-dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT04886596.
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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.