Clinical Trials Directory

Trials / Completed

CompletedNCT01062074

GARDASIL Reexamination Study (V501-059)

Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice

Status
Completed
Phase
Study type
Observational
Enrollment
3,605 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
All
Age
9 Years – 26 Years
Healthy volunteers
Accepted

Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.

Conditions

Timeline

Start date
2007-09-28
Primary completion
2013-05-07
Completion
2013-05-07
First posted
2010-02-04
Last updated
2017-04-17
Results posted
2014-03-27

Source: ClinicalTrials.gov record NCT01062074. Inclusion in this directory is not an endorsement.