Post-licensure Observational Safety Study of Gardasil 9 (V503-028)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47277
• EU PAS number:
  EUPAS13151
• Study ID:
  47277
• Official title and acronym:
  Post-licensure Observational Safety Study of Gardasil 9 (V503-028)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The V503-028 study will describe the general safety of the 9vHPV vaccine in a population of 10,000 males and females who have received at least one dose of human papillomavirus (HPV) 9-valent Vaccine (9vHPV vaccine), Gardasil 9. The general safety assessment will be conducted by estimating the risk (i.e., the incidence) of health outcomes resulting in emergency room visits or hospitalizations occurring within a pre-specified risk period after a dose of the vaccine, and comparing to the risk of such health outcomes in a post-vaccination self-comparison reference period.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Networks

Large managed care organization in the United States

Study timelines

Date when funding contract was signed

Actual: 11/08/2015

Study start date

Actual: 10/06/2016

Data analysis start date

Planned: 01/09/2019

Actual: 01/03/2019

Date of final study report

Planned: 31/12/2019

Actual: 10/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

Final_V503 PASS Study Protocol_2_final-redaction_2

Updated protocol

Final Redactions Applied_Final_V503 PASS Study Protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable