213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older (EPI-ZOSTER-044 VE US)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48446
• EU PAS number:
  EUPAS48157
• Study ID:
  48446
• Official title and acronym:
  213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older (EPI-ZOSTER-044 VE US)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  An observational retrospective study using existing data sources.
• Study status:
  Ongoing

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Planned: 09/03/2022

Study start date

Planned: 21/07/2022

Actual: 21/07/2022

Date of final study report

Planned: 26/11/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals SA

Study protocol

Initial protocol

gsk-213825-protocol-redact

Updated protocol

Protocol Amendment 1 Anonymized 16 Jul 2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)