6/28/23, 12:45 AM AReSVi-006 Pathway Feedback Search Clinical Topics Home Studies AReSVi-006 AReSVi-006 Disease Bronchiolitis Trial question What is the role of RSV prefusion F protein vaccine in older adults? Study design Multi-center Double blinded RCT Population Characteristics of study participants 52.0% female N = 24966 48.0% male 24966 patients (12915 female, 12051 male) Inclusion criteria: adults 60 years of age Key exclusion criteria: serious or unstable chronic disease; immunosuppression; history of reaction/hypersensitivity by any component of vaccine; recurrent/uncontrolled neurological disorders or seizures Interventions N=12467 RSVPreF3 OA vaccine (a single dose of an AS01E-adjuvanted RSV prefusion F protein- based candidate vaccine before RSV season) N=12499 placebo vaccine (matching placebo vaccine before RSV season) Primary outcome https://web.pathway.md/studies/recNxftENGhsVP9Y2 1/2 6/28/23, 12:45 AM AReSVi-006 Pathway Respiratory syncytial virus-related lower respiratory tract disease 5.8/1000 pt-y 5.8 4.3/1000 pt-y 2.9/1000 pt-y 1.4/1000 pt-y Significant decrease 1 0.0/1000 pt-y RSVPreF3 OA vaccine Placebo vaccine Significant decrease in RSV-related lower respiratory tract disease (1 per 1,000 participant-years vs. 5.8 per 1,000 participant-years; AD -4.8 per 1,000 participant-years, 95% CI 62.4 to 99.9) Secondary outcomes No significant difference in RSV-related acute respiratory infection (3.9 per 1,000 participant-years vs. 13.9 per 1,000 participant-years; AD -10 per 1,000 participant-years, 95% CI -20.02 to 0.02) No significant difference in RSV type A-related lower respiratory tract disease (0.3 per 1,000 participant-years vs. 1.9 per 1,000 participant-years; AD -1.6 per 1,000 participant-years, 95% CI -3.2 to 0) Safety outcomes No significant difference in serious adverse events and potential immune-mediated diseases. Significant difference in any solicited reaction (72% vs. 28%). Conclusion In adults 60 years of age, RSVPreF3 OA vaccine was superior to placebo vaccine with respect to RSV-related lower respiratory tract disease. Reference Alberto Papi, Michael G Ison, Joanne M Langley et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. Open reference URL https://web.pathway.md/studies/recNxftENGhsVP9Y2 2/2