Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00309166

Purpose

The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.

Condition	Intervention	Phase
Prophylaxis HPV Infection	Biological: HPV vaccine	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment
Official Title:	An Observer-Blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Demonstration of immunogenicity of HPV vaccine in males.

Secondary Outcome Measures:

Evaluation of safety and reactogenicity throughout the entire study.

Estimated Enrollment:	270
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

A male between, and including, 10 and 18 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment
For subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria:

Previous vaccination against Human Papillomavirus (HPV).
Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
Cancer or autoimmune disease under treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309166

Locations

Finland
GSK Investigational Site
Kouvola, Finland, 45100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Tampere, Finland, 33200

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	580299/011
Study First Received:	March 28, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00309166
Health Authority:	Finland: Ethics Committee

Study placed in the following topic categories:

Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 14, 2009