209452 - A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States

Study identification

• EU PAS number:
  EUPAS37156
• Study ID:
  50411
• Official title and acronym:
  209452 - A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 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 Recombinant zoster vaccine (RZV) in the US using a large distributed data network with a focus on specific health outcomes of interest in adults aged 50 and older.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Harvard Pilgrim Health Care Institute

Networks

Harvard Pilgrim Health Care, Aetna, CVS Health Company, Carelon Research, Humana, Optum

Study timelines

Date when funding contract was signed

Actual: 27/08/2020

Study start date

Actual: 14/09/2020

Date of final study report

Planned: 05/08/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

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)