Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Cervarix™ (HPV-16/18 L1 VLP AS04)
Intervention description: Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 10 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papillomavirus (HPV) vaccine; safety; cervical cancer; immunogenicity; vaccine; viral infections; pre-adolescent and adolescent females

Summary:

      Human papillomavirus (HPV) infection has been established as a necessary cause of cervical
      cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common
      oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.
      In previous trials, the vaccine has been found to be efficacious in the prevention of
      incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV
      vaccination should ideally be performed before onset of sexual activity. Previous studies
      showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to
      European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim
      to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy
      Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator/co-investigator believes that they and/or their
             parent(s)/legally acceptable representative(s) can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A Japanese female between, and including, 10 and 15 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s) or legally acceptable
             representative(s) of the subject. In addition, a written informed assent must be
             obtained from the subject prior to enrolment.

          -  Healthy subjects as established by medical history and history-directed clinical
             examination before entering into the study.

          -  All subjects must have a negative urine pregnancy test.

          -  Subjects must be of non-childbearing potential, or, if of childbearing potential, they
             must be abstinent or have used adequate contraception 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. Non-abstinent
             pre-menarche subjects, as well as subjects who reach menarche during study, must
             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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose or planned during study.

          -  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. Administration of
             vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment
             will be deferred until the subject is outside of specified window.

          -  Concurrently participating in another clinical study, at any time during the study
             period (up to Month 7), in which the subject has been or will be exposed to an
             investigational or a non-investigational product (pharmaceutical product or device).

          -  Previous vaccination against HPV, or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period (Day 0 to Month 7).

          -  Previous administration of components of the investigational vaccine .

          -  Cancer or autoimmune disease under treatment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Hypersensitivity to latex.

          -  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 tests.

          -  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 subject.

          -  Subject planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Oral temperature ≥ 37.5°C/Axillary temperature ≥ 37.5°C.