Maternal Outcomes following RSVpreF Vaccination during prEgnancy (MORE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Feasibility analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ABRYSVO

Population studied

• Short description of the study population:
  The Southern California Permanente Medical Group serves over 4.9 million members through 202 clinics and 16 hospitals in Southern California, offering hospital, outpatient, emergency, urgent, and home care services to a highly diverse population. The primary study cohort includes pregnant or postpartum women (aged 18–49) with live or stillbirths at ≥20 weeks gestation. A maternal-infant sub-cohort includes women from this group with a linked infant record for exploratory analysis.
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  50000

Study design details

• Study design:
  This retrospective study uses KPSC data from 2016 onward to examine RSV trends across pre‑pandemic, pandemic, and post‑RSVpreF vaccine periods, focusing on pregnant women aged 18–49 and an exploratory mother‑infant sub‑cohort to assess RSV‑related respiratory illness, potential under‑ascertainment.
• Main study objective:
  To describe the frequency and proportion of RSV-associated LRTD among pregnant and postpartum women.
• Setting:
  Southern California Permanente Medical Group is one of the largest medical groups in the U.S., including over 4.9 million members.
• Outcomes:
  RSV-LRTD will be identified using ICD-10-CM diagnostic codes in conjunction with laboratory testing performed at both outpatient and inpatient settings during the study period.
• Data analysis plan:
  The analyses encompass a thorough description of the study population’s characteristics, providing essential context for understanding the results. Additionally, the study includes descriptive analyses of laboratory testing for RSV among pregnant and postpartum women who have been clinically diagnosed with LRTD and ARI.; ; Further, the frequency and proportion of RSV-associated LRTD and RSV-associated ARI among pregnant and postpartum women are examined to better characterize the burden of disease in this population. The analyses also involve calculating the rate of laboratory testing for RSV in pregnant and postpartum people diagnosed with LRTD or ARI.; ; Finally, the study calculates the rates of ARI and LRTD among pregnant and postpartum women who have an infant with evidence of a recent RSV illness, providing insight into potential patterns or associations between maternal and infant health outcomes.