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  • Update on Moderna’s RSV Vaccine, mRESVIA (mRNA-1345), in Adults ≥60 . . .
    Efficacy of mRNA-1345 Against RSV LRTD among Adults ≥ 60 Years - 18 Month Analysis Study 301 - Per Protocol Set Vaccine protection continued over a longer period through high incidence 2022 2023 and 2023 2024 RSV seasons Lower bound of the confidence interval continued to exceed 20% Cases, n (%) RSV Vaccine (mRNA-1345) (N = 18,181) Placebo
  • Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12 . . .
    A phase 1 study was conducted to assess the reactogenicity, safety, and immunogenicity of mRNA-1345, an LNP-encapsulated mRNA-based vaccine encoding the membrane-anchored RSV F glycoprotein, in adults aged 65 to 79 years mRNA-1345 produced a robust immune response across the dose levels evaluated and was well tolerated, and no safety concerns
  • Moderna Receives U. S. FDA Approval for RSV Vaccine, mRESVIA, in Adults . . .
    The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines About Moderna Moderna is a leader in the creation of the field of mRNA medicine
  • Moderna plans triple vaccine targeting flu, COVID and RSV
    Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1 2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains The first patents have
  • Introducing the World’s First mRNA Vaccine Against RSV - Moderna
    In January 2023, we announced mRNA-1345 as our second respiratory vaccine program with positive Phase 3 trial results Our RSV vaccine is now approved in the U S We are awaiting regulatory review in multiple countries, and pending approval we look forward to launching in additional markets
  • FDA Expands Label for Modernas mRNA RSV Vaccine to Include At-Risk . . .
    Moderna’s Phase 3 study (NCT06067230) supported the approval, demonstrating that immune responses in at-risk adults under 60 met prespecified non-inferiority criteria when compared to those seen in older adults in a prior pivotal trial 2 Specifically, neutralizing antibody responses to both RSV-A and RSV-B were consistent across the subgroups aged 18 to 49 and 50 to 59 years, indicating
  • mRNA vaccine effective against RSV respiratory disease - Nature
    ciple was used to design vaccines against the for clinical trial design, regulation and data Thiago Carvalho Lisbon, Portugal Title: mRNA vaccine effective against RSV respiratory
  • RSV Vaccine (mRESVIA, mRNA-1345) Concomitant Administration Overview
    INPUT from Phase 3 Pivotal Efficacy Trial (Study 301) RSV Correlate of Protection Model Preplanned case-cohort design 6 1597 mRNA-1345 Recipients 533 Placebo Recipients 271 RSV ARD Cases1 OUTPUT • Day 1 and Day 29 sera collected from all study participants • Evaluated for RSV-A and B neutralizing titers, and Pre-F binding titers


















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