ArticleInfectious diseases and therapy2024
Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged ≥ 65.
Article in Infectious diseases and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05559476 (A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above), which is not on this map. Cited by 11 papers.
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, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
Who cites it
11 citing papers in PubMed.
- 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
- A comprehensive look at Respiratory Syncytial Virus (RSV): from pathogenesis to prevention.Tropical diseases, travel medicine and vaccines · 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
- [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
- 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
- Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRespiratory syncytial virus (RSV) and influenza pose major disease burdens in older adults due to an aging immune system and comorbidities; seasonal overlap exists between these infections. In 2023, the RSV prefusion protein F3 older adult (RSVPreF3 OA) vaccine was first approved in the USA as a single dose for prevention of lower respiratory tract disease due to RSV in adults aged ≥ 60 years. The vaccine has since been approved in the European Union and elsewhere. RSVPreF3 OA and FLU-QIV-HD could be coadministered if immunogenicity, safety, and reactogenicity are not affected.
methodsThis open-label, randomized (1:1), controlled, phase 3 study in 1029 adults aged ≥ 65 years in the USA evaluated the immunogenicity (up to 1 month after last vaccine dose) and safety (up to 6 months after last vaccine dose) of RSVPreF3 OA coadministered with FLU-QIV-HD (co-ad group) versus FLU-QIV-HD alone followed by RSVPreF3 OA at a separate visit 1 month later (control group). Non-inferiority criterion was defined as an upper limit of the two-sided 95% confidence interval of the geometric mean titer (GMT) group ratio (control/co-ad) ≤ 1.5. Secondary endpoints included safety and reactogenicity.
resultsProportions of participants across age categories between groups and proportions of male (50.4%) and female (49.6%) participants were well balanced; most participants were white (68.7%). Group GMT ratios for RSV-A neutralizing titers, hemagglutination inhibition titers for four influenza vaccine strains, and RSV-B neutralizing titers were non-inferior in the co-ad group versus the control group. No clinically meaningful differences in local or systemic solicited and unsolicited adverse events (AEs), serious AEs, and potential immune-mediated diseases were identified. The most common solicited AEs in both groups were injection-site pain and myalgia.
conclusionIn adults aged ≥ 65 years, coadministration of RSVPreF3 OA and FLU-QIV-HD was immunogenically non-inferior to the sequential administration of both vaccines 1 month apart, and had clinically acceptable safety and reactogenicity profile.
trial registrationClinicalTrials.gov identifier, NCT05559476.
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