Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01298869
Eligibility Criteria:
Inclusion Criteria:
1. Subject is between the ages 18 - 26 years as of visit 1 and has GFR \< 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 x serum creatinine(-1.154) x Age(-0.203) x 0.742 (if female)
2. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory testing.
3. Subject is able to understand study procedures and agrees to participate in the study by giving written informed consent.
4. Subject is not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU -hCG) and agrees to use effective contraception through Month 7 of the study. Effective contraception will be considered: oral contraceptives, injection or implant contraception.
5. Subject has had no temperature \> 37.8 C (oral) within 24 hours prior to the first injection.
6. Subject has no history of genital/anorectal warts,
Exclusion Criteria:
1. Subject is pregnant.
2. Subject has a history of known prior vaccination with an HPV vaccine.
3. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
4. Subject is allergic to any vaccine component, including aluminum, yeast, or BENZONASE.
5. Subject has received any immune globulin or blood derived products within the 3 months prior to the first injection, or plans to receive any through Month 7 of the study.
6. Subject has a history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled, nasal, or topical) will be eligible for vaccination.
7. Subject is immunocompromised or has been diagnosed as having HIV infection.
8. Subject has a known thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
9. Subject has a history of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse or other drug abuse.
10. Subject is unable to give informed consent.
11. Subject has any prior history of genital/anorectal warts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
26 Years
Study:
NCT01298869
Study Brief:
Protocol Section:
NCT01298869