Safety and effectiveness of RZV in adults ≥18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108331
• EU PAS number:
  EUPAS107073
• Study ID:
  108331
• Official title and acronym:
  Safety and effectiveness of RZV in adults ≥18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational study based on data extracted from database(s), which evaluates the safety and vaccine effectiveness of Shingrix, or recombinant zoster vaccine (RZV), in adults with pre-existing systemic lupus erythematosus (SLE) or multiple sclerosis (MS).
• Study status:
  Ongoing

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 24/08/2021

Actual: 24/08/2021

Study start date

Planned: 19/10/2023

Actual: 20/10/2023

Date of final study report

Planned: 15/01/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Protocol Amendment_Anonymized_215104

Regulatory

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