A phase I/II, observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years. - HPV-011
- Conditions
- In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV). In male subjects from 10 years of age onwards for the prevention of transmission of human papillomaviruses (HPV) causing persistent infections and related clinical outcomes.
- Registration Number
- EUCTR2005-005943-24-FI
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 270
All subjects must satisfy the following criteria at study entry:
• Subjects who the investigator believes that they and/or their legally acceptable representative (LAR) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• 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 LAR. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. Day 0 - 29) any dose of vaccines. Administration of routine vaccines such as meningococcal, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before any dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
• Previous vaccination against Human Papillomavirus (HPV) or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• Previous vaccination administration of MPL or AS04 adjuvant.
• Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection, or known exposure to Hepatitis B within the previous 6 weeks.
• Cancer or autoimmune disease under treatment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Hypersensitivity to latex (found in syringe-tip cap and plunger).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control (e.g. aluminium, MPL).
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F)/Axillary temperature <37.5°C (99.5°F).
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
• Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method