Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged =18 years with psoriasis or psoriatic arthritis (EPI-ZOSTER-045 VE US 216976)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108334
• EU PAS number:
  EUPAS107230
• Study ID:
  108334
• Official title and acronym:
  Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged =18 years with psoriasis or psoriatic arthritis (EPI-ZOSTER-045 VE US 216976)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational retrospective study using existing data sources.
• Study status:
  Ongoing

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Planned: 06/12/2022

Actual: 06/12/2022

Study start date

Planned: 01/11/2023

Actual: 09/11/2023

Date of final study report

Planned: 26/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Protocol Anonymized_216976

Regulatory

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