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GARDASIL Reexamination Study (V501-059)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01062074
First received: February 2, 2010
Last updated: August 7, 2014
Last verified: August 2014
  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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With Any Adverse Experience [ Time Frame: Up to 14 days after any GARDASIL vaccination ] [ Designated as safety issue: Yes ]
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

  • Percentage of Participants With Any Adverse Drug Reaction [ Time Frame: Up to 14 days after any GARDASIL vaccination ] [ Designated as safety issue: Yes ]
    An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out


Enrollment: 3605
Study Start Date: September 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Korean Participants Vaccinated with GARDASIL
Females and males 9-26 years old who are vaccinated with GARDASIL in usual practice. The GARDASIL vaccination series consists of three 0.5-mL intramuscular injections. The second and third doses are to be administered 2 months and 6 months after the first dose, respectively.

  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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062074

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01062074     History of Changes
Other Study ID Numbers: V501-059, 2010_005
Study First Received: February 2, 2010
Results First Received: February 7, 2014
Last Updated: August 7, 2014
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014