Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
Condition: Infections, Papillomavirus
Intervention: Cervarix TM; Cervarix TM
Intervention description: Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.; Intramuscular administration into the deltoid region of the non-dominant arm 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: None (Open Label)
Enrollment: 805.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV; cervical cancer; papillomavirus; Human papillomavirus (HPV) vaccine

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and
      safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an
      alternative dosing schedule as compared to the standard dosing schedule in young female
      subjects aged 15 - 25 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 believes that they and/or their parent(s)/Legally
             acceptable representative(s) (LAR) can and will comply with the requirements of the
             protocol

          -  A female between and including 15 and 25 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject prior to enrolment. For subjects
             below the legal age of consent, written informed consent must be obtained from the
             subject's parents/legally acceptable representative (LAR), and written informed assent
             must be obtained from the subject.

          -  Healthy subjects as established by medical history and/or clinical examination before
             entering into the study.

          -  Subject must be of non-childbearing potential, or if she is of child bearing
             potential, she must practice adequate contraception for 30 days prior to vaccination,
             have a negative urine pregnancy test and continue such precautions for 2 months after
             completion of the vaccination series.

          -  Subject who had no more than 6 lifetime sexual partners prior to enrolment.

        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.

          -  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. Planned
             administration/administration of routine vaccines up to 8 days before the first dose
             of study vaccine is allowed. Enrolment will be deferred until the patient is outside
             of specified window.

          -  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).

          -  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, 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.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.

          -  Pregnant or breastfeeding female.

          -  Female planning to become pregnant, likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive precautions during the study
             period starting at visit one and up to two months after the last vaccine dose.

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
             function abnormality as determined by physical examination or lab tests.