Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: HPV GSK 580299 vaccine; Placebo control
Intervention description: Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.; Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6081.0
Sex: Female
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human papillomavirus; vaccine; cervical cancer; cervical infection

Summary:

      This is a multicenter study in which women are planned to receive either the HPV vaccine or
      control. Study participation will last approximately 72 months and involves a total of
      thirteen or fourteen scheduled visits.

      Originally, the study was planned for 24 months. It was then extended for 2 more years with 4
      additional visits (study end at Month 48).

      The protocol posting has been updated as the study was extended by additional 2 years with
      two or three additional visits (study end at Month 72) for subjects who consent to
      participate in the extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese females between and including 18 and 25 years of age at the time of
             the first vaccination.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject 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.

          -  Subjects must be of non-childbearing potential, or if of childbearing potential, they
             must be abstinent or have practiced adequate contraception for 30 days prior to
             vaccination and agree to continue such precautions for 2 months after completion of
             the vaccination series.

          -  Subject must have one single intact cervix.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) 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 (up to Month 24), in which the subject has been or will be exposed to an
             investigational or a non-investigational product (pharmaceutical product or device).

          -  A subject planning to become pregnant, likely to become pregnant (as determined by the
             investigator) 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 investigational 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.

          -  History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
             cervical cytology (Pap smear) test.