209696 - A targeted safety study, EPI-ZOSTER-032 VS US DB, to evaluate the safety of Shingrix in adults ≥ 65 years of age in the United States.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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:
  Cohort

  Other
• Non-interventional study design, other:
  Targeted safety study (TSS) and a post-authorization safety study (PASS)

Study drug and medical condition

• Name of medicine:
  SHINGRIX
• Study drug International non-proprietary name (INN) or common name:
  HERPES ZOSTER VACCINE (RECOMBINANT, ADJUVANTED)
• Medical condition to be studied:
  Herpes zoster

Population studied

• Short description of the study population:
  The study population included patients aged 65 years or older who had received at least one dose of Shingrix, recombinant zoster vaccine (RZV) for the treatment of herpes zoster identified from CMS chronic conditions warehouse Medicare database from January 2017 to December 2021. ; Inclusion criteria:; US Medicare beneficiaries who meet the following criteria will be included in the study:; 1. Age 65 and older at the date of the RZV vaccination or preventive care visit for the RZV unvaccinated comparator; 2. Enrolled in Medicare due to age or ESRD as the original and current qualifying reason; 3. Continuously enrolled in Medicare Parts A, B, and D fee-for-service for at least 365 days preceding the date of RZV vaccination or preventive care visit for the RZV unvaccinated comparator. Continuous enrollment is determined by Medicare enrollment in the month of the RZV vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months.; ; Exclusion criteria:; Beneficiaries who satisfy the following criteria will be excluded:; 1. Continuously enrolled only in Medicare Part C in the baseline period, OR; 2. Enrolled in Medicare due to disability as the original qualifying reason for enrollment.
• Age groups:
  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 Shingrix, or RZV, is associated with 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 vaccination in people ≥ 65 years of age beginning January 2018 in CMS Medicare.
• 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 will include 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 For each outcome there is a primary analysis, secondary analysis and sensitivity analysis All the statistical analyses will be done in Statistical Analysis System 9.4. All the statistical tests will be two-sided at alpha level of 0.05. All 95% confidence intervals will be estimated as the point estimate +/- 1.96*standard error.