A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years
Condition: Infections, Papillomavirus
Intervention: HPV-16/18 VLP/AS04 vaccine (Cervarix TM); Placebo
Intervention description: Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 225.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical neoplasia; AS04; Randomized; Cervical cancer; HPV-16/18 L1 VLP AS04; Phase IIIb; Korea; HPV; Double-blind; Controlled

Summary:

      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to
      cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK
      Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.

      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 believes that they or their parents/guardians can and
             will comply with the requirements of the protocol should be enrolled in the study.

          -  A female between, and including, 15 and 25 years of age at the time of the first
             vaccination.

          -  Written informed assent obtained from the subject and informed consent obtained from
             the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects must have a negative urine pregnancy test.

          -  Subjects of childbearing potential at the time of study entry must be abstinent, or
             must be using adequate contraceptive precautions for 30 days prior to vaccination and
             must agree to continue such precautions for two months after completion of the
             vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study/ control vaccine within 30 days preceding the first dose of study/ control
             vaccine, or planned use during the study period.

          -  Pregnant or breastfeeding.

          -  Planning to become pregnant or likely to become pregnant.

          -  Chronic administration (defined as more than 14 days) 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. However, the
             administration of routine 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.

          -  Previous administration of components of the investigational vaccine

          -  Previous vaccination against HPV or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period.

          -  Any medically diagnosed or suspected immunodeficient condition such as HIV infection
             based on medical history and physical examination.

          -  History of thrombocytopenia or hemostatic disorder in which case the study vaccine
             should under no circumstances be administered intramuscularly.

          -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
             by any component of the study/control vaccines.

          -  Hypersensitivity to latex.

          -  Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular,
             hepatic or renal functional abnormality, as determined by previous physical
             examination or laboratory tests.

          -  History of chronic condition(s) requiring treatment.

          -  Administration of immunoglobulins and/or any blood product within three months
             preceding the first dose of study/control vaccine or planned administration during the
             study period. Enrolment will be deferred until the subject is outside of specified
             window.

          -  Acute disease at the time of enrolment.