A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years. - HPV-044 PRI

Phase 1

Conditions: For active immunization of females from the age of 10 years onwards to prevent incident and persistent infections, cytological abnormalities and cervical neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.

Registration Number: EUCTR2007-003256-11-SK

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 800

Inclusion Criteria

To be eligible for participation in the trial, subjects must fulfill all of the following inclusion criteria:
• Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
• A female between and including 15 and 25 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, written informed consent must be obtained from the subject’s parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
• Healthy subjects as established by medical history and/or clinical examination before entering into the study.
• Subject must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series. (Adequate contraception is defined in Section 5.3. in the protocol)
• Subject who had no more than 6 lifetime sexual partners prior to enrolment.

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

Exclusion Criteria

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 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., days 0 - 29) the first dose of vaccine. Planned administration/administration of routine vaccines, such as meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines, up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the patient is outside of specified window.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• Previous administration of MPL or AS04.
• Cancer or autoimmune disease under treatment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. MPL, AS04.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C.)
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Pregnant or breastfeeding female.
• Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.