GARDASIL Reexamination Study (V501-059)

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

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus (HPV) Infection

• Study Type: Observational
• Enrollment (Actual): 3605

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2007
• Primary Completion (Actual): May 7, 2013
• Study Completion (Actual): May 7, 2013

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: V501-059; 2010_005

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis