Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX(TM) (V211-024)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50065
• EU PAS number:
  EUPAS17502
• Study ID:
  50065
• Official title and acronym:
  Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX(TM) (V211-024)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This large-scale, postlicensure observational study is being conducted to assess the long-term effectiveness (over 10 years) of ZOSTAVAX(TM) (live zoster vaccine) and the real-world impact of zoster vaccination on the epidemiology of herpes zoster (HZ) when administered in routine use to people 50 years of age or older.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Networks

Large integrated healthcare system in the United States

Study timelines

Date when funding contract was signed

Actual: 30/06/2010

Study start date

Actual: 15/05/2012

Data analysis start date

Planned: 30/09/2020

Actual: 16/10/2020

Date of interim report, if expected

Planned: 31/12/2016

Actual: 15/12/2016

Date of final study report

Planned: 31/12/2020

Actual: 07/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V211-024+Protocol_final-redaction

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)

Other study registration identification numbers and links

NCT01600079