Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

• Anti-HPV-16 and anti-HPV-18 seropositivity rates and antibody titres assessed by ELISA in all subjects [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
• Occurrence of each solicited symptom [ Time Frame: During the 7 days (Days 0 - 6) after each vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited adverse events [ Time Frame: Within 30 days (Days 0 - 29) after any vaccination ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events (SAEs) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
• Occurrence of medically significant conditions (including potential immunemediated diseases) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
• Occurrence of pregnancies and pregnancy outcomes [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]

• Anti-HPV-16 and anti-HPV-18 seropositivity rates and antibody titres assessed by ELISA in all subjects [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
• Occurrence of each solicited symptom [ Time Frame: During the 7 days (Days 0 - 6) after each vaccination. ] [ Designated as safety issue: No ]
• Occurrence of unsolicited adverse events. [ Time Frame: Within 30 days (Days 0 - 29) after any vaccination. ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events (SAEs) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
• Occurrence of medically significant conditions (including potential immune-mediated diseases) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
• Occurrence of pregnancies and pregnancy outcomes [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:

• The removal of 3 outcome measures
• The update of 1 outcome measure

• Human Papillomavirus (HPV) Type 16/18 Infections
• Cervical Neoplasia

• Biological: GSK580299 (CervarixTM)
  3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
• Biological: Engerix-BTM
  3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

• Experimental: Group A
  Group receiving the HPV vaccine
  Intervention: Biological: GSK580299 (CervarixTM)
• Active Comparator: Group B
  Group receiving the hepatitis B vaccine
  Intervention: Biological: Engerix-BTM

Inclusion Criteria:

• Written informed consent prior to study enrolment.
• Healthy adult females from Chinese origin and residing in China between and including 26 and 45 years of age at the time of the first vaccination.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
• Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.

Subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine.
• 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).
• A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
• Pregnant or breastfeeding subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
• Previous administration of 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.
• Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis B infection.
• Known exposure to hepatitis B within the previous 6 weeks.
• History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminium).
• Hypersensitivity to latex.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.