Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
 genitals in men and women. Several types of HPV infection are transmitted by sexual activity
 and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
 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. If a woman is not infected by
 HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
 efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated
 cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in
 young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study
 subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine)
 administered intramuscularly according to a 0-1-6 month schedule.

 The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
 2007.
NOTE: Some 178 centers participate in this study. Given that the recruitment is completed,
 the researchers have listed one center per country in this website. If required, further
 details of centers available on request.
Inclusion Criteria:

 -  A woman whom the investigator believes that she and/or her parents/legally acceptable
 representative can and will comply with the requirements of the protocol (e.g.,
 completion of the diary cards, return for follow-up visits).

 -  A woman between, and including, 15 and 25 years of age at the time of the first
 vaccination.

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

 -  Subject must be free of obvious health problems as established by medical history and
 clinical examination before entering into the study.

 -  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 the first vaccination and must agree to continue such precautions for two
 months after completion of the vaccination series.

 -  Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion
 may not be applicable in subjects less than 18 years of age, according to local
 regulatory/ethical requirements.

 -  Subject must have intact cervix.

 Exclusion Criteria:

 -  Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not
 breastfeeding to enter the study.

 -  A woman planning to become pregnant or planning to discontinue contraceptive
 precautions during approximately the first nine months of the study (Months 0-8).

 -  Previous administration of components of the investigational vaccine.

 -  Use of any investigational or non-registered product (drug or vaccine) other than the
 study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
 use during the study period.

 -  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 before and 30 days after (i.e. days 0-29) each dose of vaccine.
 Administration of some routine vaccines up to 8 days before each dose of study vaccine
 is allowed. Enrolment will be deferred until the subject is outside of specified
 window.

 -  Previous vaccination against human papillomavirus (HPV).

 -  History of vaccination against Hepatitis A or a known clinical history of Hepatitis A
 disease.

 -  History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
 cervical cytology (Pap smear) test.

 -  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 vaccines.

 -  Hypersensitivity to latex.

 -  Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
 hepatic or renal functional abnormality, as determined by previous physical
 examination or laboratory tests.

 -  History of chronic condition(s) requiring treatment.

 -  Received immunoglobulins and/or blood product within 90 days preceding enrollment.
 Enrollment will be deferred until the subject is outside of specified window.

 -  Acute disease at the time of enrolment.

 -  Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic
 exam cannot be performed. Enrollment will be deferred until condition is resolved
 according to investigator's medical judgement.