Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: CervarixTM; Control
Intervention description: Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.; Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 750.0
Sex: Female
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Safety; Human papillomavirus; China; HPV vaccine

Summary:

      This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline
      Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects
      aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group
      will receive the control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they or their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  Healthy Chinese females between and including 9 and 17 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject and
             informed assent obtained from the subject, if appropriate, prior to enrolment.

          -  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 either of non-childbearing potential, 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 and agree to continue such
             precautions 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 (i.e., Days 0-29) 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.

          -  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 components of the study vaccine.

          -  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.

          -  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 any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.