{
  "abstract": "Background: This trial evaluated coadministration of the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) and an Omicron XBB.1.5-based coronavirus disease 2019 (COVID-19) mRNA vaccine in ≥50-year-olds.\n\nMethods: This phase 3, open-label, multicenter trial randomized ≥50-year-olds 1:1 to coadministration (Co-Ad group) or sequential administration approximately 1 month apart (Control group) of adjuvanted RSVPreF3 and the COVID-19 mRNA vaccine. Primary objectives were to demonstrate noninferiority of humoral immune responses at 1 month postvaccination in terms of RSV-A, RSV-B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers, with the upper limit of the 95% CI of adjusted geometric mean titer (GMT) group ratios (Control/Co-Ad) ≤1.50. Secondary objectives included assessment of reactogenicity up to 4 days and safety up to 6 months after vaccination.\n\nResults: Overall, 833 participants were vaccinated (Co-Ad: 417; Control: 416). Noninferiority was achieved for RSV-A (GMT ratio: 1.12 [95% CI: .97–1.28]) and RSV-B (GMT ratio: 1.08 [95% CI: .94–1.23]) and marginally missed for SARS-CoV-2 Omicron XBB.1.5 (GMT ratio: 1.31 [95% CI: 1.13–1.51]). Within 4 days postvaccination, the most frequently reported solicited events were administration-site pain, myalgia, and fatigue. Most solicited events were of mild-to-moderate intensity, and the overall median duration was ≤3 days and comparable between groups. Unsolicited and serious adverse events were generally balanced between groups.\n\nConclusions: Adjuvanted RSVPreF3 coadministered with a COVID-19 mRNA vaccine maintained an acceptable safety profile in ≥50-year-olds. The marginal miss of the noninferiority criterion for SARS-CoV-2 does not suggest clinically relevant interference. Therefore, the results support the coadministration of these vaccines.\n\nClinical Trials Registration: Clinical Trials.gov. NCT06374394.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 14,
  "authors": [
    {
      "name": "Marc Bonten"
    },
    {
      "name": "Brandon Essink",
      "orcid": "0009-0009-5765-1908"
    },
    {
      "name": "Nikita Hanning",
      "orcid": "0000-0003-0488-4248"
    },
    {
      "name": "Isabel Leroux-Roels",
      "orcid": "0000-0002-5084-4696"
    },
    {
      "name": "Cristina Masuet-Aumatell"
    },
    {
      "name": "Silvina Natalini Martinez",
      "orcid": "0000-0001-5257-547X"
    },
    {
      "name": "Hiwot Amare Hailemariam"
    },
    {
      "name": "Ghassem Jandari",
      "orcid": "0000-0002-4649-6908"
    },
    {
      "name": "Paulia Kwo Ton Ge Jua"
    },
    {
      "name": "Charlotte Servais"
    },
    {
      "name": "Sofía Valenciano",
      "orcid": "0009-0007-9740-881X"
    },
    {
      "name": "Archana M Jastorff"
    },
    {
      "name": "Vicky Cárdenas",
      "orcid": "0009-0001-9890-6243"
    },
    {
      "name": "Marie Van der Wielen",
      "orcid": "0009-0006-3808-8767"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/5gr582dxfhgn1.bib",
  "cited_by": 2,
  "doi": "10.1093/cid/ciag344",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13715961/",
  "id": "5gr582dxfhgn1",
  "issns": [
    "1058-4838",
    "1537-6591"
  ],
  "landing_url": "https://doi.org/10.1093/cid/ciag344",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "AcademicSubjects/MED00290"
    ],
    [
      "heading",
      "Major Article"
    ],
    [
      "heading",
      "Vaccines"
    ],
    [
      "openalex",
      "2713|Respiratory viral infections research"
    ]
  ],
  "openalex": "W7163548046",
  "pdf_url": "https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciag344/68475134/ciag344.pdf",
  "pmcid": "PMC13715961",
  "pmid": "42240564",
  "published": "2026-06-04",
  "publisher": "Oxford University Press",
  "ris": "https://research.draconitic.com/paper/5gr582dxfhgn1.ris",
  "sources": [
    {
      "first_seen": "2026-11-01T12:23:08Z",
      "native_id": "PMC13715961",
      "source": "pmc",
      "url": "https://doi.org/10.1093/cid/ciag344"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2713|Respiratory viral infections research",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Immunogenicity and Safety of Coadministration of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine and a COVID-19 mRNA Vaccine in Adult s Aged ≥50 Years: A Phase 3, Randomized, Noninferiority Trial",
  "title_text": "Immunogenicity and Safety of Coadministration of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine and a COVID-19 mRNA Vaccine in Adult s Aged ≥50 Years: A Phase 3, Randomized, Noninferiority Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:23:08Z",
  "url": "https://research.draconitic.com/paper/5gr582dxfhgn1",
  "venue": "Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America",
  "versions": []
}