A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting (V501-031)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17731
• EU PAS number:
  EUPAS17730
• Study ID:
  17731
• Official title and acronym:
  A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting (V501-031)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study describes the general safety of Gardasil™ when administered to females as part of routine medical care at a large integrated healthcare system.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Two large integrated healthcare systems in the United States California

Study timelines

Date when funding contract was signed

Actual: 04/11/2007

Study start date

Actual: 08/01/2007

Data analysis start date

Actual: 06/01/2008

Date of final study report

Actual: 13/12/2010

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

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

Study Number: V501-031NCT number: NCT01078220