Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
Brief Summary: Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.


Options:
A: Inclusion Criteria:

* Healthy, unmarried females age 16 to 23 years with intact uteri
* Not pregnant at enrollment
* Agreed to use effective contraception through Month 7 of the study
* A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria:

* No prior history of Human Papillomavirus (HPV) vaccination
* No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
* No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
B: 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
C: Inclusion Criteria:

* Study participants who the investigator or delegate believes that they and/or their 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) should be enrolled in the study.
* A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.

A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.

Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study.

* Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse).
* Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement.
* If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Previous vaccination against HPV or Hepatitis B virus.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F) / Rectal temperature \<38°C (100.4°F).)
* Pregnant or lactating female.
D: 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.

Answer: A