Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013
Brief Summary: This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Inclusion criteria :

* Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
* Subjects must have a negative urine pregnancy test.
* Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
* Subject must have an intact cervix

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period.
* Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
* A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose
* previous administration of components of the investigational vaccine
* 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 the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine.
* Previous vaccination against HPV.
* History of vaccination against hepatitis A or a known clinical history of hepatitis A disease
* Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* History of allergic disease 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.
* Cancer or autoimmune disease under treatment.
* History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
* Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed
* Acute disease at the time of enrolment.
* Oral temperature \>= 37.5°C / axillary temperature \> 37.5°C.
* 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).
B: Inclusion Criteria:

* Lifetime history of 0-4 sexual partners

Exclusion Criteria:

* History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
C: Inclusion Criteria:

* A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
* Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

* 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).
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* 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 3 months preceding blood sampling.
D: Inclusion Criteria:

* Female between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap (Papanicolaou) test results
* For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
* For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in the base study and received ≥1 dose of GARDASIL

Exclusion Criteria:

* History of an abnormal cervical biopsy result
* History of a positive test for HPV
* History of external genital/vaginal warts
* Currently a user of any illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received marketed HPV vaccine or participated in an HPV trial
* Currently enrolled in a clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)

Answer: C