Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: HPV Vaccine (GSK580299) Cervarix TM; Engerix B
Intervention description: IM administration; IM administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 744.0
Sex: Female
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Co-administration; HPV vaccine; Cervical cancer

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent
      vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and
      safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18
      L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents/legally
             acceptable representatives (LARs) 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 female between, and including, 9 and 15 years of age (has not attained her 16th
             birthday) at the time of the first vaccination.

          -  Written informed consent obtained from the subject's parent/LAR prior to the
             enrolment. In addition, written informed assent must be obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects must not be pregnant. Absence of pregnancy should be verified with a urine
             pregnancy test.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for at least 30 days
             prior to vaccination, have a negative pregnancy test and continue such precautions for
             two months after completion of the vaccination series. Subjects who reach menarche
             (begin menstruating) during the study, and therefore become of childbearing potential,
             must agree to follow the same precautions.

        Exclusion Criteria:

          -  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 (up to Month 12).

          -  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 each dose of vaccine. Administration of
             routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus
             and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of
             study vaccine is allowed.

          -  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).

          -  A subject planning to become pregnant, likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive precautions during the study
             period and up to two months after the last vaccine dose.

          -  Pregnant or breastfeeding women.

          -  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 components of the investigational vaccine.

          -  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.

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality, as determined by previous physical examination or laboratory tests.

          -  Cancer or autoimmune disease under treatment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  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 any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.