A post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-only

Study drug and medical condition

• Name of medicine:
  AREXVY
• Study drug International non-proprietary name (INN) or common name:
  RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E
• Medical condition to be studied:
  Atrial fibrillation

  Guillain-Barre syndrome

  Encephalomyelitis
• Additional medical condition(s):
  New-onset Guillain-Barré syndrome; New-onset Acute Disseminated Encephalomyelitis ; New-onset Atrial fibrillation

Population studied

• Short description of the study population:
  Health plan members ≥50 years of age are included in study if they: 1) received one dose of Arexvy; 2) had 365 days of continuous medical and pharmacy enrolment prior to Arexvy vaccine receipt; 3) had continuous enrolment through the end of the follow-up period; 4) had no evidence of a second dose of Arexvy vaccine during the follow-up period; and 5) had no evidence of another medical product indicated for RSV disease prevention prior to receipt of Arexvy vaccine or during the follow-up period.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  4400000

Study design details

• Study design:
  Non-interventional study
• Main study objective:
  To evaluate whether Arexvy vaccine is associated with an increased risk of new-onset Guillain-Barré syndrome (GBS) and new-onset acute disseminated encephalomyelitis (ADEM), within specified time periods after vaccination among people ≥50 years of age.
• Setting:
  Health plan administrative claims data held by 5 Research partners who are participating in the US FDA’s Sentinel System.
• Outcomes:
  New-onset GBS in adults ≥50 years of age in the US using claims;; New-onset ADEM in adults ≥50 years of age in the US using claims;; New-onset AF (atrial fibrillation) in adults ≥50 years of age in the US using claims.;
• Data analysis plan:
  Demographic and clinical characteristics of the study (vaccinated) and analytic (vaccinated with outcomes in risk or control periods) cohorts will be described. SCRI-based analyses will use conditional Poisson regression models.
• Summary results:
  A result summary report will be completed at the end of the study.