Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Exclusion Criteria

• •Pregnant or breastfeeding.
• •A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
• •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
• •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or planned administration during the study period.
• •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine. Planned administration/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.
• •Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
• •History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
• •Hypersensitivity to latex.
• •Known acute or chronic, clinically significant neurologic, 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 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
• •Acute disease at the time of enrolment.
• •Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
• •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 (pharmaceutical product or device).
• •Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
• •Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.