Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
Condition: Infections, Papillomavirus
Intervention: GSK580299 (Cervarix)
Intervention description: 3-dose schedule intramuscularly vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: Female
Minimum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Serious adverse events (SAEs); HPV vaccine; Medically significant conditions; Cervical neoplasia

Summary:

      This extension study is designed to assess the safety of GSK Biological's human
      papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study
      NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV
      vaccine is not indicated for the subject's age group (26 years and older). This study is thus
      conducted to enable all women who received the control placebo in the primary NCT00294047
      study to receive the GSK580299 vaccine.
    

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 NCT00294047, who received the control vaccine,
             and who cannot receive the GSK580299 vaccine because the subject is above the age for
             which the vaccine is licensed.

          -  Written informed consent obtained from the subject

          -  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.

          -  A women planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the vaccination phase of the study, i.e.
             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. For corticosteroids, this will mean
             prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical
             steroids are allowed

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days (i.e., Day 0-29) of each dose of 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. Enrolment 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.

        NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological
        follow-up of the HPV-015 study, in which no investigational product will be administered.
        Subjects will be invited to the gynaecological follow-up study if either of the following
        applies:

          -  if they test positive for oncogenic HPV infection, but display normal cervical
             cytology at their concluding HPV-015 study end visit;

          -  if they are pregnant so that no cervical sample can be taken at their concluding
             HPV-015 study end visit;

               -  Previous administration of any components of the vaccine.

               -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based
                  on medical history and physical examination.

               -  Cancer or autoimmune disease under treatment.

               -  Administration of immunoglobulins and/or any blood products within the 3 months
                  preceding the first dose of study vaccine or planned administration during the
                  study period.

               -  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 enrolment.

               -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or
                  renal functional abnormality, as determined by physical examination or laboratory
                  screening tests.