A Study of Gardasil (V501) in Preadolescents and Adolescents - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092547

Purpose

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine, Gardasil (V501), in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Condition	Intervention	Phase
Healthy Papillomavirus Infections	Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 1.5 years	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Safety and Immunogenicity Study of Gardasil (V501) Quadravalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents

Further study details as provided by Merck:

Primary Outcome Measures:

Tolerability.

Secondary Outcome Measures:

Immune response post dose 3.

Estimated Enrollment:	1650
Study Start Date:	November 2003

Eligibility

Ages Eligible for Study:	9 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adolescents and preadolescents with no prior sexual history.

Exclusion Criteria:

Subjects with compromised immune system or have a history of severe allergic reaction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092547

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_084, V501-018
Study First Received:	September 23, 2004
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00092547
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
DNA Virus Infections
Papillomavirus Infections
Healthy

Additional relevant MeSH terms:

Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009