GARDASIL Reexamination Study (V501-059)

Human Papillomavirus (HPV) Infection Clinical Trial

Official title:

Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062074
• Other study ID #: V501-059
• Secondary ID: 2010_005
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: February 4, 2015
• Start date: September 2007
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3605
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 26 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus (HPV) Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Any Adverse Experience	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.	Up to 14 days after any GARDASIL vaccination	Yes
Primary	Percentage of Participants With Any Adverse Drug Reaction	An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out	Up to 14 days after any GARDASIL vaccination	Yes