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 institution and networks

Institutions

Merck & Co.
First published:
01/02/2024
Institution
Two large integrated healthcare systems in the United States California

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme Corp.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Actual:

Date of final study report

Actual:
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)