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
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

  • 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

800000
Study design details

Main study objective

To assess VE among individuals at KPSC who received RZV (“vaccinated”) compared to individuals who did not receive RZV (“RZV unvaccinated”) with 10 years of follow-up.

Outcomes

The VE of 2 doses of RZV in preventing HZ and the VE of 2 doses of RZV in preventing PHN in adults aged ≥ 50 years, when the second dose is received 4 weeks to 6 months after the first dose, during a 10 year follow up period post second dose of vaccination.
RZV VE-2 doses preventing HZ&PHN stratified by age, sex& race/ethnicity, RZV VE-2 doses preventing HZ by prevalent comorbidities at baseline &ZVL history, HZ incidence in vaccinated(2 doses) & unvaccinated adults, by HZ history, RZV VE-2 doses preventing HZO, hospitalized AMI &hospitalized stroke, doses given 4 weeks-6 months post 2nd dose. RZV VE-1 dose preventing HZ&PHN in adults post 1st dose

Data analysis plan

The number and characteristics of individuals will be described and compared. Categorical variables will be presented as absolute numbers and percentages with p-values for the χ2 test.
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.
All the statistical calculations will be performed using SAS software package (version 9.4). Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) comparing HZ incidence rates in the 2-dose (4 weeks to 6 months) RZV cohort and the matched unvaccinated cohort will be estimated by Cox proportional hazards regression models adjusting for potential confounders.