GARDASIL Reexamination Study (V501-059)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Human Papillomavirus (HPV) Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01062074

2010_005

V501-059

Details and patient eligibility

About

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.

Enrollment: 3,605 patients

Sex: All

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

3,605 participants in 1 patient group

Korean Participants Vaccinated with GARDASIL

Description:

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.