ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial.
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 NCT04841577 (A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above), which is not on this map. Cited by 27 papers, 1 of them a synthesis 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, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- 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
- Coadministration of mRNA-1345 RSV vaccine with high-dose quadrivalent influenza vaccine in adults aged 65 and older: An observer-blinded, placebo-controlled, randomized, phase 3 trial.Human vaccines & immunotherapeutics · 2026Trial
- Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults ≥ 50 Years of Age.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial.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
- Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine.The Journal of infectious diseases · 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
- 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 · 2024Trial
- Review
- AS01Drug safety · 2026Article
- Catching our breath: development of interventions and therapies for respiratory syncytial virus.Microbiology and molecular biology reviews : MMBR · 2026Review
- Respiratory Syncytial Virus Immunization Strategies for Older Adults in Gulf Cooperation Council Countries: Expert Consensus and Recommendations.Infectious diseases and therapy · 2026Article
- Vaccination Against Respiratory Infections in Adults with Cancer: A Concise Guide for Clinicians.Vaccines · 2026Review
- Advances and prospects of respiratory mucosal vaccines: mechanisms, technologies, and clinical applications.NPJ vaccines · 2025Review
- [Recommendations on prevention and treatment of respiratory infections in institutionalised older people].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025Review
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- Optimal Timing of Vaccination: A Narrative Review of Integrating Strategies for COVID-19, Influenza, and Respiratory Syncytial Virus.Infectious diseases and therapy · 2025Review
- [Ways to improve vaccination rates : Indication vaccinations for adults].Innere Medizin (Heidelberg, Germany) · 2025Article
- Adult Vaccine Coadministration Is Safe, Effective, and Acceptable: Results of a Survey of the Literature.Influenza and other respiratory viruses · 2025Review
- Characteristics of the First Italian Older Adults Vaccinated with an Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine.Medicina (Kaunas, Lithuania) · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCo-administration of vaccines against respiratory syncytial virus (RSV) and influenza can be considered given their overlapping seasonality, and may increase vaccine uptake and compliance. In this phase 3, open-label, randomized study, we evaluated the immunogenicity, reactogenicity, and safety of the AS01E-adjuvanted RSV prefusion F protein-based candidate vaccine (RSVPreF3 OA) when co-administered with a seasonal quadrivalent influenza vaccine (FLU-QIV) in older adults.
methodsParticipants aged ≥60 years (randomized 1:1) received either RSVPreF3 OA and FLU-QIV simultaneously on day 1 (Co-Ad group) or FLU-QIV on day 1 followed by RSVPreF3 OA on day 31 (sequential administration [SA] group). The co-primary objectives were to demonstrate noninferiority of RSVPreF3 OA in terms of RSV-A neutralization geometric mean titer (GMT) ratio and FLU-QIV in terms of hemagglutination inhibition GMT ratio for each FLU-QIV strain, when co-administered versus when administered alone at 1-month post-vaccination. Noninferiority was demonstrated if the upper limit of the 95% confidence interview of the group GMT ratio (SA/Co-Ad) was ≤1.5. Secondary descriptive objectives comprised additional immunogenicity assessments, reactogenicity, and safety.
resultsOf the 885 participants who received one dose of the study vaccines, 837 were included in the per protocol set. Demographic and baseline characteristics were balanced between the groups. Both co-primary objectives were met for both vaccines. Reported adverse events in both groups were mild-to-moderate, with a low frequency of grade 3 events.
conclusionsData from this study demonstrate that RSVPreF3 OA can be co-administered with FLU-QIV. Co-administration is well tolerated, with an acceptable safety profile. CLINICALTRIALS.GOV REGISTRATION: NCT04841577.
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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.