GARDASIL Reexamination Study (V501-059)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 2, 2010
Last updated: February 4, 2015
Last verified: February 2015
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.

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)
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.


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

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 identifier: NCT01062074

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. 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: February 4, 2015
Health Authority: Korea: Food and Drug Administration processed this record on February 08, 2016