Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Condition: Infections, Papillomavirus
Intervention: Placebo; HPV-16/18 L1 VLP AS04 (Cervarix TM)
Intervention description: Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of vaccine 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: 271.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV-16/18 L1 VLP AS04; Cervical neoplasia; Cervical cancer; Human Papillomavirus (HPV); Double-blind; AS04

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
      HPV-16/18 L1 VLP AS04 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 can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A female from Malaysia between, and including, 18 and 35 years of age at the time of
             the first vaccination.

          -  Written informed consent obtained from 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 an effective method of birth control 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  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. 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 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(s).

          -  Hypersensitivity to latex.

          -  Acute disease at the time of enrolment.

          -  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 vaccine(s) or planned administration during the
             study period. Enrolment will be deferred until the subject is outside of specified
             window.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.