GARDASIL Reexamination Study (V501-059)

NCT01062074 | Completed Results

• 2 other identifiers: V501-0592010_005
• Study Type: observational
• Target: 3,605
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Papillomavirus (HPV) Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Participant Who Has A Contraindication To Gardasil According To The Local Label
• Participants Who Are Vaccinated With Gardasil Before Study Start

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Papillomavirus Infections; Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: September 28, 2007
• Primary Completion: May 7, 2013
• Study Completion: May 7, 2013
• Last Updated: April 17, 2017
• Results First Posted: March 27, 2014

Record last verified: 2017-03