Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.
Brief Summary: The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.


Options:
A: Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.
B: Inclusion Criteria:

* Females between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap test results.
* Lifetime history of 0 to 4 sexual partners

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 illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received a marketed HPV vaccine
* 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)
C: Inclusion criteria:

* A woman who the investigator believes that she can and will comply with the requirements of the protocol.
* A women of at least 26 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subject must have intact cervix.
* Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential.
* Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:

* Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
* A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8).
* 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 during the study period (up to Month 84).
* 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) 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.
* Previous administration of components of the investigational vaccine
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.
* 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 vaccine.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* History of chronic condition(s) requiring treatment.
* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. 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 pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.
D: Inclusion Criteria:

* Female between and including 15 and 25 years of age at the time of screening (must not have reached 26th birthday)
* Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must also be obtained from a parent or legal guardian of the subject)
* Free of obvious health problems, as established by medical history and a directed physical examination
* No more than 6 lifetime sexual partners prior to enrolment
* Intact uterus
* Subject must be of non-childbearing potential, i.e., either surgically sterilised or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
* For subjects not enrolled in the HPV epidemiology study (999910/106) and for subjects completing the study (999910/106) \>90 days prior to enrolment in the present study: agreement to complete both entrance and exit study questionnaires concerning general personal information, and sexual, contraceptive, reproductive and other gynaecological medical history
* For subjects previously enrolled in the HPV epidemiology study (and who completed the study and an entrance questionnaire) ≤ 90 days prior to enrolment in the present study: agreement to complete the exit questionnaire only.
* Normal cervical cytology (Pap smear) at screening, using the Cytyc ThinPrep® Pap Test. A normal Pap smear must also be adequate for interpretation, including the presence of endocervical cells; a Pap smear that is normal but inadequate for interpretation must be repeated as part of the protocol
* Seronegative for HPV-16 and HPV-18 antibody by ELISA at screening
* HPV DNA PCR negative for high-risk HPV types by PCR at screening. Genotyping will be specified using a reverse line probe assay specific for the detection of high-risk HPV types such as HPV-16, HPV-18 and HPV-16/18-related phylogenetic types

Exclusion Criteria:

* Pregnant or lactating female
* Female planning to become pregnant during the first eight months of the study (months 0-8)
* Abnormal vaginal discharge at the time of entry (once these subjects have received therapy to eradicate any discharge they will be eligible to participate in study)
* Previous administration of any components of the investigational vaccine
* Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period
* Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine. Administration of routine Meningococcal, Hepatitis A, Hepatitis B, Influenza, and Diphtheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
* Receiving or expecting therapy for external or internal condylomata. Subjects with external condylomata not requiring therapy are eligible to participate in the study
* Genital herpes disease involving the cervix or characterized (on examination or by history) by extensive external lesions. Subjects with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study
* History of an abnormal cervical cytology (Pap smear) test (other than a single prior report of ASCUS with a subsequent normal report)
* Treatment for cervical disease by ablative therapy (cryotherapy or laser ablation) or excisional therapy (laser cone biopsy, loop excision, cold-knife conization)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* A family history of congenital or hereditary immunodeficiency
* Major congenital defects or serious chronic illness
* History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
* Acute disease at the time of enrolment.
* Oral temperature ≥99.5°F (≥37.5°C) / axillary temperature ≥99.5°F (37.5°C) / rectal temperature ≥100.4°F (≥38.0°C) / tympanic temperature on oral setting ≥99.5°F (37.5°C) / tympanic temperature on rectal setting ≥100.4°F (≥38.0°C)
* History of chronic alcohol consumption and/or intravenous drug abuse within the past 2 years
* Known or suspected allergy to any vaccine component
* Hepatomegaly, right upper quadrant abdominal pain or tenderness

Answer: D