Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.

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


Options:
A: Inclusion Criteria:

* Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
* No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
* Additional criteria will be discussed with you by the physician

Exclusion Criteria:

* Concurrently enrolled in a clinical study involving collection of genital specimens
* History of known prior vaccination with an HPV vaccine
* Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
* History of a severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 6 months prior to the first study injection
* History of splenectomy, immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with HIV infection
* Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
B: Inclusion Criteria:

* A woman whom the investigator believes can and will comply with the requirements of the protocol.
* A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
* Written informed consent must be obtained from the subject prior to enrolment.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subject must be of non-childbearing potential, or if of child bearing potential, she must have a negative pregnancy test and she 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.
* Subject who has had no more than 6 lifetime sexual partners prior to enrolment.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to six months after last dose of vaccine.
* Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine.
* 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) the first dose of study 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. 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 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.
* Previous administration of components of the investigational vaccine
* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination 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.
* Cancer or autoimmune disease under treatment.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
* History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology test.
* Received immunoglobulins and/or blood product within 3 months preceding enrolment or planned administration during the study period up to one month after the last dose of vaccine. Enrolment 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 cervical sample cannot be collected. Enrolment will be deferred until condition is resolved according to investigators medical judgement.
C: Inclusion Criteria:

* No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
* Not pregnant and agrees to use effective contraception through Month 7 of the study
* Additional criteria applied

Exclusion Criteria:

* Pregnant
* Concurrently enrolled in a clinical study involving collection of cervical specimens
* Previously received any HPV vaccine
* History of severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 3 months prior to the first study injection
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
* Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
* Prior treatment for genital warts, VIN, or VaIN
* History of cervical disease (ie, surgical treatment for cervical lesions)
* Hysterectomy
D: 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).

Answer: B