Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
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.
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 NCT05568797 (A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV), which is not on this map. Cited by 15 papers.
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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 III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
Who cites it
15 citing papers in PubMed.
- 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 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
- Review
- Respiratory Syncytial Virus Vaccination as Cardiopulmonary and Cardiovascular Risk Mitigation in Adults with Heart Disease.Journal of clinical medicine · 2026Review
- 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
- AS01Drug safety · 2026Article
- Respiratory Syncytial Virus Immunization Strategies for Older Adults in Gulf Cooperation Council Countries: Expert Consensus and Recommendations.Infectious diseases and therapy · 2026Article
- Concurrent Mold, Mycobacterial, and Viral Infections in a Hematopoietic Stem Cell Transplant Recipient Undergoing Lung Transplantation for Graft-Versus-Host Disease.Current oncology (Toronto, Ont.) · 2026Article
- Vaccination Against Respiratory Infections in Adults with Cancer: A Concise Guide for Clinicians.Vaccines · 2026Review
- [Recommendations for vaccination of adults for respiratory physicians].Pneumologie (Stuttgart, Germany) · 2026Review
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- 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
- Real-world feasibility of co-administration of RSV, COVID-19, and influenza vaccines in older adults: a VAERS-based analysis.Frontiers in pharmacology · 2025Article
- Cost-effectiveness of the adjuvanted RSVPreF3 vaccine among adults aged ≥60 years in the United States.Human vaccines & immunotherapeutics · 2024Article
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.
methodsThis phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed.
resultsOverall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06-1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups.
conclusionsAdjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine. CLINICAL TRIALS REGISTRATION: NCT05568797.
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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.