Post-Licensure Observational Study of the Safety of GARDASIL(TM) in Males (V501-070)

Study identification

• EU PAS number:
  EUPAS17675
• Study ID:
  50012
• Official title and acronym:
  Post-Licensure Observational Study of the Safety of GARDASIL(TM) in Males (V501-070)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a post-licensure observational cohort study to describe the general safety of GARDASIL(TM) in males by estimating the rate of health outcomes resulting in an emergency room visit or hospitalization in a pre-defined risk period after vaccination, the rate of specific events (e.g. syncope, epilepsy, convulsions, and allergic reactions) on the day of vaccination, and the rate of new-onset autoimmune conditions after vaccination.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Networks

Large healthcare claims database in the United States

Study timelines

Date when funding contract was signed

Actual: 06/04/2010

Study start date

Actual: 23/06/2011

Data analysis start date

Planned: 01/06/2019

Actual: 01/06/2019

Date of interim report, if expected

Actual: 09/12/2016

Date of final study report

Planned: 31/12/2019

Actual: 28/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

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

NCT01567813,V501-031