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

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ClinicalTrials.gov Identifier: NCT01355003
Recruitment Status : Terminated (Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study)
First Posted : May 17, 2011
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease
Papillomavirus Infections

Study Type : Observational
Actual Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol
Study Start Date : February 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Group/Cohort
All Participants
Participants who were vaccinated with GARDASIL™ by their physician



Primary Outcome Measures :
  1. Number of participants with adverse events following any dose of vaccine [ Time Frame: At least 30 days following any vaccine dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   All
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™

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01355003     History of Changes
Other Study ID Numbers: V501-077
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

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