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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/49979
• EU PAS number:
  EUPAS49294
• Study ID:
  49979
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  A retrospective matched cohort database study to provide early real-world evidence of the effectiveness of RZV in patients aged 50 years of age and older with autoimmune diseases in the United States.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 22/08/2022

Study start date

Planned: 14/10/2022

Actual: 14/10/2022

Date of final study report

Planned: 29/10/2024

Actual: 29/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals SA

Study protocol

Initial protocol

Redacted Protocol Anonymized 29 Sep 2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable