GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

This study has been terminated.
(Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01355003
First received: May 16, 2011
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

This study will collect safety information on the use of GARDASIL™ in the Philippines.


Condition
Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with adverse events following any dose of vaccine [ Time Frame: At least 30 days following any vaccine dose ] [ Designated as safety issue: Yes ]

Enrollment: 1080
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Participants
Participants who were vaccinated with GARDASIL™ by their physician

  Eligibility

Ages Eligible for Study:   9 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Received GARDASIL™
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01355003     History of Changes
Other Study ID Numbers: V501-077
Study First Received: May 16, 2011
Last Updated: August 9, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 29, 2014