Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
Brief Summary: Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men


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:

* Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
* Subject is a man who has had no more than 5 lifetime female sexual partners.
* Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
* Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Exclusion Criteria:

* Subject who has had sex with a male partner.
* Subject has a history of HPV-related external genital lesions or HPV-related anal lesions
* Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE
* Subject has a history of severe allergic reaction that required medical intervention.
* Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Subject is concurrently enrolled in clinical studies of investigational medicinal products.
* Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
* Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Subject has had a splenectomy.
* Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response.
* Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
* Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
* Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
* Subject has had a fever within the 24-hour period prior to the Day 1 vaccination.
* Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
* Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
* Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
* Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.
C: Inclusion Criteria:

* A woman whom the investigator believes that she and/or her 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).
* A woman between, and including, 15 and 25 years of age at the time of the first vaccination.
* Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent).
* Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subject must have a negative urine pregnancy test.
* Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
* Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.
* Subject must have intact cervix.

Exclusion Criteria:

* Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8).
* Previous administration of components of the investigational vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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.
* 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) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous vaccination against human papillomavirus (HPV).
* History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease.
* History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
* 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 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.
* History of chronic condition(s) requiring treatment.
* Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment 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. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.
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: B