Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
Brief Summary: The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.


Options:
A: DISEASE CHARACTERISTICS:

•Healthy participants

* Deemed to be in good general health by history and physical examination

  •Resident of Guanacaste Province of Costa Rica and surrounding areas
* Must remain a resident for ≥ 6 months after the first study vaccination

PATIENT CHARACTERISTICS:

Age

* 18 to 25

Performance status

•Not specified

Life expectancy

•Not specified

Hematopoietic

•Not specified

Hepatic

* No history of chronic hepatitis requiring treatment
* No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings
* No known history of hepatitis A infection

Renal

* No history of kidney disease requiring treatment
* No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings

Cardiovascular

* No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary
* No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology
* No history of allergic disease
* No history of autoimmune disorder requiring treatment
* No history of allergic reaction (e.g., difficulty breathing) to any vaccine
* No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin)
* No hypersensitivity to latex
* No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other
* Not pregnant or nursing

  ◦No delivery within the past 3 months
* Negative pregnancy test
* Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment
* Able to speak or understand Spanish
* Mentally competent
* Able to undergo pelvic exam (i.e., no heavy bleeding \[menstruation or otherwise\] or heavy vaginal discharge)
* No history of cancer requiring treatment
* No history of diabetes requiring treatment
* No history of other chronic conditions requiring treatment
* No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings
* No other acute disease
* No fever ≥ 37.5º C

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 6 months since prior chronic administration (i.e., \> 14 days) of immune-modulating drugs
* More than 90 days since prior immunoglobulins
* More than 30 days since prior and no other concurrent investigational or non-registered vaccines
* More than 30 days since prior registered vaccines
* More than 8 days since prior routine meningococcal, hepatitis B, influenza, or diphtheria/tetanus vaccine
* No prior vaccination against hepatitis A
* No prior vaccination against human papillomavirus
* No prior monophosphoryl lipid A or AS04 adjuvant

Chemotherapy

•Not specified

Endocrine therapy

* More than 6 months since prior chronic administration (i.e., \> 14 days) of corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent)
* Concurrent inhaled or topical steroids allowed

Radiotherapy

•Not specified

Surgery

•No prior hysterectomy

Other

* More than 6 months since prior chronic administration (i.e., \> 14 days) of immunosuppressants
* More than 30 days since prior and no other concurrent investigational or non-registered drugs
B: Inclusion Criteria:

All Participants:

-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results

Boys and Girls 9 to 14 Years:

-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period

Women 16 to 26 Years:

* Has never had a Papanicolaou (Pap) test or only had normal Pap test results
* A lifetime history of 0 to 4 male and/or female sexual partners

Exclusion Criteria:

All Participants:

* Known allergy to any vaccine component
* History of severe allergic reaction that required medical intervention
* Thrombocytopenia or any coagulation disorder
* Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
* Currently immunocompromised, or been diagnosed with immunodeficiency
* Had a splenectomy
* Receiving or has received immunosuppressive therapies within the last year
* Received any immunoglobulin product or blood-derived product within 3 months
* Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
C: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
* A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
* Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject's parents/legally acceptable representative, and written informed assent must be obtained from the subject.
* Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
* Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 24).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* 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. 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.
* Pregnant or breastfeeding female.
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
* Previous administration of components of the investigational vaccine.
* Cancer or autoimmune disease under treatment.
* Any medically diagnosed 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 vaccine.
* Hypersensitivity to latex.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period (up to Month 24).
D: Inclusion Criteria:

* Healthy Chinese subject who participated in V501-030 in Per-protocol population.
* Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
* Subject is willing to give consent/assent.

Exclusion Criteria:

* Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
* Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
* Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030

Answer: D