209570 - Long-Term Effectiveness Study of Shingrix in Adults ≥ 50 Years of Age in the US (EPI-ZOSTER-031 VE US)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46860
• EU PAS number:
  EUPAS38633
• Study ID:
  46860
• Official title and acronym:
  209570 - Long-Term Effectiveness Study of Shingrix in Adults ≥ 50 Years of Age in the US (EPI-ZOSTER-031 VE US)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will evaluate the long-term Vaccine Effectiveness (VE) among individuals ≥ 50 Years who received RZV compared to individuals who did not receive RZV, followed for up to 10 years following the last dose of RZV.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Actual: 30/05/2020

Study start date

Actual: 18/12/2020

Date of final study report

Planned: 14/10/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-209570-protocol-redact-01

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)