Eligibility Details:
Inclusion Criteria:
- Has provided written informed consent for the study. The participant may also provide
consent for future biomedical research. However, the participant may participate in
the main study without participating in future biomedical research.
- Agrees to provide study personnel with a primary telephone number as well as an
alternate means of contact, if available (such as an alternate telephone number or
email) for follow-up purposes
- Can read, understand, and complete the electronic vaccination report card (eVRC)
- Has had at least 1 lifetime sexual partner
Exclusion Criteria:
- Has a history of human papillomavirus (HPV)-related anal lesion (anal intraepithelial
neoplasia or anal cancer) or HPV related head and neck cancer
- Has a history of or clinical evidence at the Day 1 external genital examination of
HPV-related external lesion
- Has clinical evidence at the Day 1 external genital examination of gross genital
lesion suggesting sexually transmitted disease
- Has a fever (defined as oral temperature ≥100.0°F or ≥37.8°C)
- Has a history of severe allergic reaction (e.g., swelling of the mouth and throat,
difficulty breathing, hypotension, or shock) that required medical intervention
- Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE®
- Has known thrombocytopenia or any coagulation disorder that would contraindicate
intramuscular injections
- Is currently immunocompromised or has been diagnosed as having congenital or acquired
immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus,
rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or
other autoimmune condition
- Has a history of splenectomy
- 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 or alcohol abuse or
dependence at the discretion of the investigator. Alcohol abusers are defined as those
who drink despite recurrent social, interpersonal, and/or legal problems because of
alcohol use.
- Has received within 12 months prior to enrollment, is receiving, or plans to receive
during the study, the following immunosuppressive therapies: radiation therapy,
cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin,
leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including
rituximab [RITUXAN®]), intravenous immunoglobulin (IVIG), anti-lymphocyte sera, or
other therapy known to interfere with the immune response. Regarding systemic
corticosteroids, a participant will be excluded if he is currently receiving steroid
therapy, has recently received such therapy, or has received 2 or more courses of
high-dose corticosteroids (≥20 mg/day of prednisone [or equivalent] orally or
parenterally) lasting at least 1 week in duration in the year prior. Participants
using inhaled, nasal, or topical steroids are considered eligible for the study.
- Has received within the 3 months prior to vaccination, is receiving, or plans to
receive during the study, any immune globulin product (including RhoGAMâ„¢) or
blood-derived product other than IVIG
- Has received inactivated or recombinant vaccines within 14 days prior to vaccination
or receipt of live vaccines within 21 days prior to vaccination
- Is concurrently enrolled in other clinical studies of investigational agents
- Has previously received a marketed HPV vaccine, or has participated in a clinical
trial for any HPV vaccine (receiving either active agent or placebo)
- Has engaged in sexual activity 48 hours prior to vaccination. Sexual activity is
defined as: penile penetrative vaginal intercourse with female partner; penile
penetrative or receptive anal intercourse with male or female partner; or oral sex
involving any contact between participant's mouth with a female partner's vagina or
genital area or male partner's penis or genital area.
- Is unlikely to adhere to the study procedures, keep appointments, or is planning to
permanently relocate from the area prior to the completion of the study or to leave
for an extended period when study visits would need to be scheduled
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
child) who is investigational site or Sponsor staff directly involved with this study
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
