GARDASIL Reexamination Study (V501-059)

Completed

• Conditions: Human Papillomavirus (HPV) Infection

• Registration Number: NCT01062074
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-04
• Primary Completion: 2013-05-07
• Study Completion: 2013-05-07
• Results First Submitted: 2014-02-07
• Results First Submitted QC: 2014-02-07
• Results First Posted: 2014-03-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3605

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Any Adverse Drug Reaction	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
Percentage of Participants With Any Adverse Experience	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.