Human Papillomavirus (HPV) Registration Study (Gardasil) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157950

Purpose

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Condition	Intervention	Phase
Papillomavirus Infections	Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine/Duration of treatment: 7 months	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea

Further study details as provided by Merck:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	176
Study Start Date:	November 2005

Eligibility

Criteria

Inclusion Criteria:

Girls ages 9 to 15 years (must not yet have had coitarche)
Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)

Exclusion Criteria:

All Subjects:

Women Ages 16 to 23 Only:

Individuals with any prior history of genital warts or treatment for genital warts.
Individuals with > 3 lifetime male or female sexual partners.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157950

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_066, V501-023
Study First Received:	September 7, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00157950
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Merck:

Human Papilloma Virus

Study placed in the following topic categories:

Virus Diseases
DNA Virus Infections
Papillomavirus Infections
Papilloma

Additional relevant MeSH terms:

Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009