Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
Brief Summary: This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.


Options:
A: Inclusion Criteria:

* A woman between, and including, 18 and 25 years of age at the time of the first vaccination
* Written informed consent from the subject prior to enrolment
* Subject must be free of obvious health problems
* Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria:

* Pregnant or breastfeeding
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
* Previous vaccination against human papillomavirus (HPV)
B: Inclusion Criteria:

A woman between, and including, 10 and 14 years of age at the time of the first vaccination.

Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test.

Exclusion Criteria:

Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.

History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.

Previous vaccination against human papillomavirus (HPV).
C: Inclusion Criteria:

* Males age 18-26

Exclusion Criteria:

* Hospitalization within the past year
* Previous HPV vaccination

  \>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
* History of genital warts
* Immunosuppression
* Other vaccines within 8 days of proposed HPV vaccination
* Hypersensitivity to yeast or HPV vaccine components
* Known autoimmune disorders
* Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
* Serious Adverse Reaction to HPV vaccine
D: 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

Answer: D