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GARDASIL Reexamination Study (V501-059)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062074
First Posted: February 4, 2010
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: Observational Model: Other
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 ]
    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 ]
    An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out


Enrollment: 3605
Actual Study Start Date: September 28, 2007
Study Completion Date: May 7, 2013
Primary Completion Date: May 7, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062074


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01062074     History of Changes
Other Study ID Numbers: V501-059
2010_005
First Submitted: February 2, 2010
First Posted: February 4, 2010
Results First Submitted: February 7, 2014
Results First Posted: March 27, 2014
Last Update Posted: April 17, 2017
Last Verified: March 2017