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
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 April 17, 2014