{
  "abstract": "Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTIs) in infants and children. No active RSV vaccine is currently available for children. mRNA-1345 is an investigational mRNA-based RSV vaccine encoding the prefusion F (preF) glycoprotein.\n\nMethod: This phase 2, randomized, observer-blind study evaluated a single dose of mRNA-1345 in children aged 2 to <18 years who were healthy (2 to <5 years only) or had stable chronic conditions associated with increased RSV risk. Children aged 2 to <5 years received 7.5-, 15-, or 30-µg mRNA-1345 or placebo, whereas children aged 5 to <18 years received 15-, 30-, or 50-µg mRNA-1345. The primary objective was safety and reactogenicity (Part A); the secondary objective was immunogenicity. RSV surveillance was conducted from 6 to 12 months post-immunization in a subset of re-enrolled participants from the 2- to <5-year-old cohort (Part B).\n\nResults: Overall, 346 participants received study vaccination. Across dose levels and age cohorts, mRNA-1345 was well tolerated, with no vaccine-related serious adverse events or discontinuations. mRNA-1345 elicited robust increases in RSV-A and RSV-B neutralizing antibody titers and preF-biased responses by day 29. During Part B surveillance, RSV infections were infrequent, with no severe/hospitalized RSV-LRTIs.\n\nConclusions: mRNA-1345 demonstrated a favorable safety profile and was immunogenic in a predominantly RSV-seropositive pediatric population. These results support potential further clinical development of this vaccine in children aged >2 years at increased RSV risk, with further evaluation required to characterize the benefit-risk profile in RSV-naïve children.\n\nClinical Trials Registration: NCT06097299",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "name": "Jennifer Moore",
      "orcid": "0009-0001-1828-2152"
    },
    {
      "name": "Hui Qian"
    },
    {
      "name": "Sonia K Stoszek"
    },
    {
      "name": "Richard Bennett"
    },
    {
      "name": "Shelly Senders"
    },
    {
      "name": "Scott Striplin"
    },
    {
      "name": "Jennifer L Nayak",
      "orcid": "0000-0002-5042-3031"
    },
    {
      "name": "Matthew D Snape"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/2djc34pxn47g5.bib",
  "cited_by": 0,
  "doi": "10.1093/ofid/ofag679",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13728700/?tool=EBI",
  "id": "2djc34pxn47g5",
  "issns": [
    "2328-8957"
  ],
  "landing_url": "https://europepmc.org/article/PMC/PMC13728700",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "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 and Immunization"
    ],
    [
      "openalex",
      "2713|Respiratory viral infections research"
    ]
  ],
  "openalex": "W7222848431",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13728700/pdf/?tool=EBI",
  "pmcid": "PMC13728700",
  "pmid": "42979232",
  "published": "2026-10-17",
  "publisher": "Oxford University Press",
  "ris": "https://research.draconitic.com/paper/2djc34pxn47g5.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T15:20:47Z",
      "native_id": "PMC:PMC13728700",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13728700"
    },
    {
      "first_seen": "2026-11-07T12:21:38Z",
      "native_id": "PMC13728700",
      "source": "pmc",
      "url": "https://doi.org/10.1093/ofid/ofag679"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2713|Respiratory viral infections research",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Safety and Immunogenicity of an mRNA Respiratory Syncytial Virus Vaccine, mRNA-1345, in Healthy and High-Risk Pediatric Populations Aged 2 to 17 Years",
  "title_text": "Safety and Immunogenicity of an mRNA Respiratory Syncytial Virus Vaccine, mRNA-1345, in Healthy and High-Risk Pediatric Populations Aged 2 to 17 Years",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T12:21:38Z",
  "url": "https://research.draconitic.com/paper/2djc34pxn47g5",
  "venue": "Open forum infectious diseases",
  "versions": []
}