GARDASIL Reexamination Study (V501-059)

N/ACompletedNCT01062074

Merck Sharp & Dohme LLC3,605 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,605

Conditions

Human Papillomavirus (HPV) Infection

Eligibility

Sex: ALLMin age: 9 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Up to 14 days after any GARDASIL vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.