Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
Condition: Infections, Papillomavirus
Intervention: CervarixTM (GSK580299)
Intervention description: Three intramuscular injections
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: Female
Minimum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine; serious adverse events (SAEs); medically significant conditions; cervical neoplasia

Summary:

      This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV
      vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and
      received a placebo in the HPV-001 (NCT00689741) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in
             Study HPV-001 (NCT00689741), and who is 26 years of age or older.

          -  Written informed consent must be obtained from the subject prior to enrollment.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the subject
             has practiced adequate contraception for 30 days prior to vaccination, and has a
             negative pregnancy test on the day of vaccination, and has agreed to continue adequate
             contraception during the entire treatment period and for 2 months after completion of
             the vaccination series.

        Exclusion Criteria:

          -  Pregnant or breastfeeding: enrollment should be deferred to at least three months
             after delivery and after breastfeeding is ceased.

          -  A woman planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the vaccination phase of the study, and
             up to two months after the last vaccine dose.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Previous vaccination against HPV or planned administration of another HPV vaccine
             during the study other than that foreseen in the protocol.

          -  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 of each dose of the vaccine, with the exception of administration of
             routine meningococcal, hepatitis B, hepatitis A, inactivated influenza,
             diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before
             each dose of study vaccine. Enrollment will be deferred until the subject 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.

          -  Previous administration of vaccine components.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Cancer or autoimmune disease under treatment.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrollment. Enrollment will be deferred
             until condition is resolved.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests, which in the opinion of the investigator precludes administration of the study
             vaccine.