209452 - A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Self-controlled risk interval design (a version of the self-controlled case series and the case-crossover designs)

Study drug and medical condition

• Name of medicine:
  SHINGRIX
• Study drug International non-proprietary name (INN) or common name:
  RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK) Varicella zoster vaccines

  Varicella zoster vaccines
• Medical condition to be studied:
  Herpes zoster

Population studied

• 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:
  723000

Study design details

• Main study objective:
  To assess whether there is an increased risk of new-onset Guillain-Barré Syndrome (GBS), Gout, Polymyalgia Rheumatica (PMR), Giant Cell Arteritis (GCA), Ischemic Optic Neuropathy (ION) or Supraventricular Tachycardia (SVT) within specified time periods after RZV vaccination in people ≥ 50 years of age enrolled starting in January 2018 at any of the participating U.S. Research Partners.
• Outcomes:
  The risk of new onset GBS (within 42 days) and Gout (within 30 days) following RZV vaccination using a Self-controlled Risk Interval (SCRI) design and the risk of new onset PMR (within 183 days) and GCA (within 183 days) following RZV vaccination using a cohort design. The risk of new onset SVT within 30 days following RZV vaccination using a SCRI design and the risk of new onset ION within 183 days following RZV vaccination using a cohort design.
• Data analysis plan:
  The analysis plan includes descriptive measures to characterize exposed and unexposed individuals, conditional Poisson regression models for the SCRI, and Cox proportional hazards regression models for the cohort design outcomes Sentinel analytic tools will be used for the distributed analyses, modifications to the tools may be needed to meet study objectives. For each outcome there is a primary analysis, secondary analysis and sensitivity analysis. All the statistical calculations will be done in SAS 9.2 or higher.