A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)

Korábbi kezelés

• Has received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
• Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood derived product other than IVIG.
• Has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
• Has received any marketed HPV vaccine other than the 2vHPV vaccines.

Más betegség

• Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer.
• Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer.
• Has a history of a positive test for HPV (including HPV types not in the vaccine).
• Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
• Has a history of splenectomy.

Egyéb

• The main exclusion criteria include but are not limited to the following:

• The main inclusion criteria include but are not limited to the following:
• For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus [HPV] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1.
• For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.