Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Brief Summary: Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.


Options:
A: Inclusion Criteria:

1. 11-13 years of age.
2. Signed informed consent form (both parent's \& daughter's signature).
3. Good health status.
4. Able to comply with trial protocol.
5. Plans to stay at current school for duration of study.

Exclusion Criteria:

1. Prior HPV vaccination
2. Pregnant or lactating or intends to become pregnant during study period.
3. Apparent moderate or severe acute illness.
4. Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
5. Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
6. Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past.
7. Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
B: Inclusion Criteria:

* A female between, and including, 9-13 years (before 14th birthday) and 16-26 years of age (before 27th birthday) at the time of the first vaccination.
* Healthy
* Not pregnant
* Four or less sexual partners over lifetime as reported by subject. (Sexual activity is defined as intercourse)
* Not planning to become pregnant or likely to become pregnant
* No reported history of genital warts
* No laboratory confirmed history of cervical intraepithelial neoplasia
* No previous vaccination against HPV
* No administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
* No previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
* No confirmed or suspected immunosuppressive or immunodeficient condition based on medical history
* No bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* Cannot be already enrolled in any clinical trial in which investigational vaccine or drug are being administered

Exclusion Criteria

* Pregnant
* Female planning to become pregnant or likely to become pregnant (as determined by the investigator) during the study duration Part 1 (0-7 months)
* Reported history of genital warts
* Laboratory confirmed history of cervical intraepithelial neoplasia
* Greater than four lifetime sexual partners involving sexual intercourse
* Previous vaccination against HPV
* Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
* A previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history (e.g. HIV infection, genetic defect, immunosuppressive therapy). \*Chronic administration (defined as more than 14 days) of immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study period is exclusionary (corticosteroid use - immune-modifying level is ≥0.5 mg/kg/day; inhaled or topical steroids are acceptable).
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopaenia, coagulation disorder, anti-coagulant therapy).
* Enrollment in any clinical trial in which investigational vaccine or drug are being administered
C: Inclusion Criteria:

* Female between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap (Papanicolaou) test results
* For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
* For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in the base study and received ≥1 dose of GARDASIL

Exclusion Criteria:

* History of an abnormal cervical biopsy result
* History of a positive test for HPV
* History of external genital/vaginal warts
* Currently a user of any illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received marketed HPV vaccine or participated in an HPV trial
* Currently enrolled in a clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)
D: 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.

Answer: B