Study identification

PURI

https://redirect.ema.europa.eu/resource/50012

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 & Co.
First published:
01/02/2024
Institution

Networks

Large healthcare claims database in the United States

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme LLC

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

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

V501-070-01 Protocol Summary

English (319.33 KB - PDF)View document
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)