Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.
Condition: Human Papillomavirus (HPV) Infection
Intervention: Cervarix; Placebo Al(OH)3
Intervention description: The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.; Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 676.0
Sex: Female
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Immunogenicity; Human Papillomavirus (HPV) vaccine

Summary:

      Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000
      new cases are reported each year worldwide, from which 83% occur in developing countries. The
      incidence of cervical cancer varies depending on the region of the world. Africa has some of
      the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7
      and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8
      per 100 000; Middle Africa 28.0 and 23.0 per 100 000).

      As in the majority of developing countries, organization of cervical cancer screening
      programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic
      vaccination could therefore clearly and efficiently decrease the incidence of cervical
      cancer. The current study is designed to assess the immunogenicity and safety of GSK
      Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in
      Africa.

      Ideally, HPV vaccination should be performed before onset of sexual activity, since studies
      have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will
      therefore be performed in subjects aged 10 to 25 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents/legally
             acceptable representative can and will comply with the requirements of the protocol
             should be enrolled in the study.

          -  A female between, and including, 10 and 25 years of age at the time of the first
             vaccination.

          -  Written or oral, signed or thumb printed or witnessed informed consent obtained from
             the subject prior to enrolment. For subjects below legal age of consent, written or
             oral, signed or thumb printed or witnessed informed consent obtained from the
             subject's parent or legally acceptable representative. In addition, a written or oral,
             signed or thumb printed and witnessed informed assent must be obtained from the
             subject.

          -  Free of obvious health problems as established by medical history, clinical
             examination and laboratory testing before entering into the study.

          -  Subjects must have a negative urine pregnancy test at the screening visit and at Visit
             1 (Day 0).

          -  Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening
             visit.

          -  Subjects must be of non-childbearing potential, or, if of childbearing potential, she
             must be abstinent or have used adequate contraceptive precautions for 30 days prior to
             vaccination, have a negative pregnancy test and must agree to continue such
             precautions for two months after completion of the vaccination series. Subjects who
             reach menarche during the study and therefore are of childbearing potential must agree
             to follow the same precautions.

          -  Subjects must have had no more than 6 sexual partners prior to enrolment.

          -  Subjects must be willing to undergo HIV voluntary counselling and testing and must be
             willing to be informed of their HIV status. Subjects below legal age of consent must
             also be willing to have their parent or legally acceptable representative informed of
             their HIV status.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines 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 or planned administration during the study
             period.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days before
             the first dose of vaccine. Enrolment will be deferred until the subject is outside of
             specified window.

          -  Planned administration of a vaccine not foreseen by the study protocol within 30 days
             before and 30 days after any dose of study vaccine.

          -  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.

          -  Cancer or autoimmune disease under treatment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV infection based on laboratory testing performed during the screening visit.

          -  Hypersensitivity to latex.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine/control.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory testing
             performed at the screening visit.

          -  History of any neurologic disorders or seizures.

          -  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.

          -  Pregnant or breastfeeding female.

          -  A women planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the study period, up to two months after
             the last vaccine dose.

          -  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).