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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Papillomavirus

Treatments: Biological: Engerix-B vaccine; Biological: Cervarix vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309166

580299/011

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: Male

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Cervarix Group

Experimental group

Description:

Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.

Treatment:

Biological: Cervarix vaccine

Engerix-B Group

Active Comparator group

Description:

Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.

Treatment:

Biological: Engerix-B vaccine