Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX(TM) (V211-024)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, open study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK02) zoster, live attenuated

  zoster, live attenuated
• Medical condition to be studied:
  Herpes zoster

  Post herpetic neuralgia

Population studied

• Short description of the study population:
  The study cohort included KPNC members diagnosed with herpes zoster receiving ZOSTAVAX™ on the day they become age-eligible. The study cohort refreshed annually to include members of aged 50 years or older.; Inclusion criteria:; - The study cohort was limited to KPNC members with continuous KPNC membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date (referred to as the “baseline period”). ; - Continuous membership since becoming age-eligible ensured accurate information on vaccination and HZ occurrence. ; - The 12-month baseline period was also needed for the assessment of several study variables, such as immune compromise status and co-morbid conditions, and for the evaluation of certain exclusion criteria.; ; Exclusion criteria:; - a HZ diagnosis in the baseline period; - receipt of ZOSTAVAX™ prior to study start date; - joining KPNC after age-eligibility (i.e., individuals ≥60 years of age who joined KPNC after May 2006 and individuals ≥50 years of age who joined KPNC after March 2011).
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with herpes zoster
• Estimated number of subjects:
  30000

Study design details

• Main study objective:
  The objective of the study is to assess the effectiveness of the vaccine against HZ and postherpetic neuralgia (PHN) in people vaccinated at 50 years of age or older, overall, by age at vaccination, and by time since vaccination.
• Outcomes:
  Herpes zoster, Postherpetic neuralgia
• Data analysis plan:
  Vaccine effectiveness is estimated by comparing the incidence of HZ and PHN in vaccinated and unvaccinated individuals through Cox regression models. Vaccine effectiveness is estimated by Cox proportional hazards models utilizing stratification on birth year, and adjusted for time-fixed and time-varying covariates.

Documents

Study results

V211-024v01-final-report-dec-2020_Final Redaction

Study report

V211-024+Interim+Report+ENCePP_final-redaction

Study publications

Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier …

Baxter R, Bartlett J, Fireman B, Marks M, Hansen J, Lewis E, Aukes L, Chen Y, K…