Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
Condition: Infections, Papillomavirus
Intervention: GSK580299 (CervarixTM); Engerix-BTM
Intervention description: 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6); 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1212.0
Sex: Female
Minimum age: 26 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; HPV vaccine; Immune response; Human papillomavirus; China

Summary:

      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).
    

Eligibility criteria:

        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.