Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
Brief Summary: 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 consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.


Options:
A: Inclusion Criteria:

* A woman between, and including, 10 and 25 years of age at the time of the first vaccination.
* Written informed consent from the subject prior to enrolment.
* Subject must be free of obvious health problems.
* Subject must have negative urine pregnancy test.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
* Previous vaccination against human papillomavirus (HPV).
B: Inclusion Criteria:

* Trial Cohort (16-17 years at baseline) - the cohort of Finnish subjects who participated in the GSK Biologicals' HPV-008 trial (NCT00122681):
* Cohort A: subjects who received HPV-16/18 L1 VLP AS04 vaccine between May 2004 and May 2005.
* Cohort B: subjects who received the Hepatitis A control vaccine. All subjects were offered the HPV-16/18 L1 VLP AS04 vaccine at the end of the study (age 21-22).
* Cohort B1: subjects who received the Hepatitis A control vaccine and then received cross-over HPV vaccination at HPV-008 study end.
* Cohort B2: subjects who received the Hepatitis A control vaccine and who did not receive cross-over HPV vaccination at HPV-008 study end.
* Referent cohort (18-19 years at baseline):
* Cohort C: A population-based reference cohort of female subjects from Finland who have not been exposed to any HPV vaccine enrolled in this study in May 2005, immediately after recruitment of the HPV-008 clinical trial subjects had been stopped (approximately 9,000 subjects).

Exclusion Criteria:

* Trial Cohort (Cohort A and B): Previous or planned administration of an HPV vaccine not foreseen by the HPV-008 study protocol or any HPV-008 extension study protocol (Gardasil or any experimental HPV vaccine).
* Referent cohort (Cohort C): Previous or planned administration of an HPV vaccine (Cervarix, Gardasil or any experimental HPV vaccine).
C: Inclusion criteria:

* A woman who the investigator believes that she can and will comply with the requirements of the protocol.
* A women of at least 26 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subject must have intact cervix.
* Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential.
* Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:

* Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
* A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8).
* 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 84).
* 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) 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 or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.
* 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 three 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.
* Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.
D: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
* A female between, and including, 9 and 25 years of age at the time of the first vaccination
* Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
* Healthy subjects
* 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 vaccination period and up to two months after the last study vaccine dose

Exclusion Criteria:

* Pregnant or breastfeeding
* A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
* Previous vaccination against HPV or planned administration of another HPV vaccine during the study
* Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
* 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
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines
* Cancer or autoimmune disease under treatment
* Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. 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 is allowed. 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
* Previous administration of MPL or AS04 adjuvant.
* 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
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* Family history of congenital or hereditary immunodeficiency
* Major congenital defects or serious chronic illness
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine
* Acute disease and/or fever at the time of enrolment

Answer: A