Please select the eligibility criteria that correspond to the clinical trial below.
Title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).


Options:
A: Inclusion Criteria:

* Young women age 16 years and 0 days to 23 years and 364 days
* HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA \> 1,000 copies/ml
* HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads \< 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

* Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
* Anticipated ability and willingness to complete all study vaccines and evaluations
* Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

* History of any prior vaccination with an HPV vaccine
* Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
* Previous allergic reaction to any constituents of the HPV vaccine
* Pregnancy
* Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
* Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
* Presence of any known \> Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
* Receipt of any routine vaccine within four weeks prior to study entry
* Receipt of any immune globulin or plasma product within six months prior study entry
* Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
* Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
* Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
* Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
* Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for \> 2 consecutive weeks)
* Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
* Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
* If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment
B: Inclusion Criteria:

* Aged between 13 and 15 years at the time of the first immunisation
* Female
* No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
* Written informed consent obtained from parent or guardian of subject

Exclusion Criteria:

* Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
* Breast-feeding mothers
* Allergic to vaccine components
C: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
* A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
* Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be 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.
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
* Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
D: Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.

Answer: C