Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Infection with human papillomavirus (HPV) has been clearly established as the central cause
 of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
 uterus or womb). This infection may go away by itself, but if it does not go away (this is
 called persistent infection), it can lead in women over a long period of time to cancer of
 the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals
 HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.
 Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly
 according to a 0-1-6 month schedule. The study will be extended to assess long-term safety
 and immunogenicity of the HPV-16/18 vaccine.
Inclusion criteria for primary study:

 -  A woman who the investigator believes that she and/or her parents/legally acceptable
 representative can and will comply with the requirements of the protocol.

 -  A woman between, and including, 15 and 55 years of age at the time of the first
 vaccination.

 -  Written informed consent obtained from the subject prior to enrolment (for subjects
 below the legal age of consent, written informed consent must be obtained from a
 parent or legally acceptable representative and, in addition, the subject should sign
 and personally date a written informed assent).

 -  Free of obvious health problems.

 -  Subject must have a negative urine pregnancy test.

 -  Subject must be of non-childbearing potential or, if of childbearing potential, she
 must be abstinent or must be using adequate contraceptive precautions for 30 days
 prior to vaccination and must agree to continue such precautions for two months after
 completion of the vaccination series. Subjects who reach menarche during the study and
 therefore become of childbearing potential must agree to follow the same precautions

 Inclusion criteria for extension studies

 -  A female who enrolled in the primary study and received three doses of vaccine.

 -  Written informed consent obtained from the subject prior to enrolment (for subjects
 below the legal age of consent, written informed consent must be obtained from a
 parent or legally acceptable representative and, in addition, the subject must sign
 and personally date a written informed assent).

 Exclusion criteria for primary study:

 -  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.

 Exclusion criteria for extension studies

 -  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.