Observational study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022 and HZ efficacy, immunogenicity and safety of HZ/su by frailty status (ZOSTER-064)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  To determine, by evaluation of frailty, if the study population is representative of the general population
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  This is a retrospective, observational study, therefore no new subjects will be enrolled in this study

Study drug and medical condition

• Medical condition to be studied:
  Herpes zoster

Population studied

• Short description of the study population:
  Adults aged ≥50 years of age who participated in either ZOSTER006 or ZOSTER-022.; Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER022 were excluded.
• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  25000

Study design details

• Main study objective:
  To assess the baseline frailty of subjects enrolled in the ZOSTER-006 and ZOSTER-022 studies.
• Outcomes:
  The primary outcome of this study is the assessment of baseline frailty status of subjects enrolled in Zoster 006 and Zoster 022. •SF-36 and EQ-5D scale scores at months 0, 14, 26 and 38. •Confirmed HZ cases during the entire study period (3 to 5 year period following Day 0). •Herpes Zoster Burden of Illness Score, by Frailty Status during the entire study period. •Solicited local and general AE, Unsolicited AE, Serious Adverse Events (SAEs) and Potential Immune-Mediated Diseases (pIMDs). •Humoral Immunogenicity.
• Data analysis plan:
  An analysis will be carried out at the end of the study.