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

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

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.

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.