209696 - A targeted safety study, EPI-ZOSTER-032 VS US DB, to evaluate the safety of Shingrix in adults ≥ 65 years of age in the United States.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48959
• EU PAS number:
  EUPAS37133
• Study ID:
  48959
• Official title and acronym:
  209696 - A targeted safety study, EPI-ZOSTER-032 VS US DB, to evaluate the safety of Shingrix in adults ≥ 65 years of age in the United States.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Targeted safety study to assess the real-world safety of Shingrix vaccine in the US using the Centers for Medicare and Medicaid Services (CMS) Chronic Condition Warehouse (CCW) database with a focus on specific health outcomes of interest in adults aged 65 and older.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 18/08/2020

Study start date

Planned: 11/09/2020

Actual: 11/09/2020

Date of final study report

Planned: 23/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Redacted EPI-ZOSTER-032 Protocol Amendment 3 Anonymized 16 Aug 2022

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)