Study Stopped
Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol
1 other identifier
observational
1,080
0 countries
N/A
Brief Summary
This study will collect safety information on the use of GARDASIL™ in the Philippines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2008
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 17, 2011
CompletedAugust 13, 2015
August 1, 2015
2.3 years
May 16, 2011
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events following any dose of vaccine
At least 30 days following any vaccine dose
Study Arms (1)
All Participants
Participants who were vaccinated with GARDASIL™ by their physician
Eligibility Criteria
Data will be collected from physicians who prescribed GARDASIL™ and who voluntarily agree to provide information on their patients. Each physician can provide up to five reports corresponding to five patients.
You may qualify if:
- Received GARDASIL™
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 17, 2011
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
August 13, 2015
Record last verified: 2015-08