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GARDASIL Reexamination Study (V501-059 AM5)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01062074
First received: February 2, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Human Papillomavirus (HPV) Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percentage of participants with any adverse experience [ Time Frame: During or within 14 days following the first vaccination and from the time of any subsequent vaccination through 14 days thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3600
Study Start Date: September 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Korean Participants
Females and males 9-26 years old who are vaccinated with GARDASIL in usual practice

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Females and males 9-26 Years Of Age who are vaccinated with GARDASIL in usual practice

Criteria

Inclusion Criteria:

  • Females and males 9-26 years of age who Are Vaccinated With The First Dose Of Gardasil For The Prevention Of Any Disease Caused By Human Papillomavirus (e.g., Cervical Cancer, Genital Warts, etc.) Within Local Labeling

Exclusion Criteria:

  • Participant Who Has A Contraindication To Gardasil According To The Local Label
  • Participants Who Are Vaccinated With Gardasil Before Study Start
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062074

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01062074     History of Changes
Other Study ID Numbers: V501-059, 2010_005
Study First Received: February 2, 2010
Last Updated: May 14, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013