219111- A retrospective matched cohort database study in the United States to evaluate the effectiveness of recombinant zoster vaccine (RZV) in patients with autoimmune diseases (AIDs) (EPI-ZOSTER-097 VE US DB)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective matched cohort database study

Study drug and medical condition

• Name of medicine:
  SHINGRIX
• Study drug International non-proprietary name (INN) or common name:
  HERPES ZOSTER VACCINE (RECOMBINANT, ADJUVANTED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK03) zoster, purified antigen

  zoster, purified antigen
• Medical condition to be studied:
  Herpes zoster

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  42755

Study design details

• Main study objective:
  To estimate the VE of 2 doses of RZV in preventing HZ in participants with one of the following conditions: Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis (PsO) or Psoriatic Arthritis (PsA).
• Outcomes:
  Number of HZ cases after 2 RZV doses in participants with SLE, MS, RA, IBD, PsO and PsA.
• Data analysis plan:
  The number and characteristics of participants in each cohort will be described and compared. Categorical variables such as gender will be presented as absolute numbers and percentages with p-values for the Pearson χ2 test or Fisher’s exact test, as appropriate. Continuous variables such as age in years will be presented as the mean with standard deviation and/or median with interquartile ranges, with p-values for the two-sample t-test or Wilcoxon rank-sum test, as appropriate. Absolute standardized differences will be calculated to assess the balance of covariates with a cut-off value of 0.20. Overall incidence rates of HZ for the 2-dose (>28 days apart) and the 1-dose RZV vaccinated cohort and the matched unvaccinated cohort will be calculated by dividing the number of HZ cases by the total number of person-years.

Documents

Study report

Clinical Study Report Anonymised.pdf