Trial reportInfluenza and other respiratory viruses2024
The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.
Trial report in Influenza and other respiratory viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 16 papers, 2 of them syntheses that pooled 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.
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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- 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
- The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.Influenza and other respiratory viruses · 2024Trial
- Adjuvanted RSVPreF3 vaccine impact over three respiratory syncytial virus seasons in older adults with comorbidities.ERJ open research · 2026Article
- Health-related Quality of Life in European Older Adults with Respiratory Syncytial Virus Over Three Respiratory Syncytial Virus Seasons.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Recent developments of vaccines for older adults: Adjuvants and beyond.Human vaccines & immunotherapeutics · 2025Review
- A Cluster Randomized Study to Explore Case Definitions, Clinical Course and Consequences of RSV in Community-Dwelling Adults Aged ≥ 50 Years.Infectious diseases and therapy · 2025Article
- Vaccinations for Elite Athletes.Vaccines · 2025Article
- Innovation in the Design of Clinical Trials for Infectious Diseases: Focusing on Patients Over Pathogens.Pharmaceutical medicine · 2025Review
- Correction to "The Respiratory Syncytial Virus Prefusion F Protein Vaccine Attenuates the Severity of RSV-Associated Disease in Breakthrough Infections in Adults ≥60 Years of Age".Influenza and other respiratory viruses · 2025Article
- Development, Current Status, and Remaining Challenges for Respiratory Syncytial Virus Vaccines.Vaccines · 2025Review
- Perceived benefits, information, vaccination history, and conspiracy beliefs as significant determinants of RSV vaccine acceptance among Arab seniors.Therapeutic advances in vaccines and immunotherapy · 2025Article
- Vaccination Strategies in Respiratory Diseases: Recommendation from AIPO-ITS/ETS, SIMIT, SIP/IRS, and SItI.Respiration; international review of thoracic diseases · 2025Review
- Cost-effectiveness of the adjuvanted RSVPreF3 vaccine among adults aged ≥60 years in the United States.Human vaccines & immunotherapeutics · 2024Article
- Review
- Correction to: The Respiratory Syncytial Virus Prefusion F Protein Vaccine Attenuates the Severity of RSV-Associated Disease in Breakthrough Infections in Adults ≥60 Years of Age.Influenza and other respiratory viruses · 2024Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
18 authors at 11 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group ( Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.
Indexed as
Identifiers
What OpenQuestion holds
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.