Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

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.