Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
Condition: Infections, Papillomavirus
Intervention: Cervarix
Intervention description: Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Female
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hong Kong; Human papillomavirus; Safety

Summary:

      This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus
      (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses
      of commercially available HPV vaccine before they are 25 years, and were placebo recipients
      in the primary study (NCT00306241).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects enrolled in the primary study (NCT00306241) who received the placebo
             (aluminium hydroxide [Al(OH)3]).

          -  A female who is unable to receive all three doses of commercially available Cervarix
             before her 25th birthday.

          -  Written informed consent obtained from the subject (prior to enrolment).

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects must have a negative urine pregnancy test.

          -  Subjects must be of non-childbearing potential or, if the subject is of childbearing
             potential, she must be abstinent (and if so, this must be documented in the source
             documents at each vaccination visit) or must be using adequate contraception for 30
             days prior to vaccination and continue 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  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
             non-investigational product (pharmaceutical product or device).

          -  Pregnant or breastfeeding.

          -  Planning to become pregnant or likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive prevention during the study
             period and up to two months after the last vaccine dose.

          -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
             by any component of the study vaccine.

          -  Hypersensitivity to latex (found in syringe-tip cap and plunger).

          -  Known acute or chronic, clinically significant neurologic, haematological, hepatic or
             renal functional abnormality, as determined by previous physical examination or
             laboratory tests.

          -  Cancer or autoimmune disease under treatment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Previous administration of an adjuvant that used in the HPV-16/18 vaccine.

          -  Previous vaccination against HPV or planned administration of another HPV vaccine
             during the study.

          -  Acute disease at the time of enrolment.