Safety and protective effect study of GSK Biologicals’ Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in healthy female subjects from the HPV-039 study

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject prior to performing any study specific procedure.
• Subjects previously enrolled in the HPV-039 study.
• Subjects with negative pregnancy test at Visit 1. Additional inclusion criteria for subjects of HPV group undergoing vaccination ONLY:
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.

Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

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 vaccine/product (pharmaceutical product or device).

• Previous vaccination against HPV outside of study HPV-039. Additional exclusion criteria for subjects of HPV group undergoing vaccination ONLY:
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before and after each dose of vaccine administration, with the exception of administration of routine vaccines e.g. meningococcal, hepatitis B, hepatitis A, inactivated influenza up to eight days before and after each dose of study vaccine. Enrolment will be deferred until the subject is outside of the specified window.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Previous administration of MPL or AS04 adjuvant.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Cancer or autoimmune disease under treatment.
• Hypersensitivity to latex.
• Acute disease and/or fever at the time of enrolment.

Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

• Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
• Females planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.