9-valent HPV Vaccine in Postpartum Women (NCT04311528) | Clinical Trial Compass
UnknownPhase 4
9-valent HPV Vaccine in Postpartum Women
100 participantsStarted 2020-04-01
Plain-language summary
This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.
Who can participate
Age range16 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* Female between the ages of 16 and 45 years of age at enrollment
* Postpartum (Day 1 vaccination to occur within 1 week of delivery)
* Judged to be in good health on the basis of medical history and physical examination
* Able to fully understand study procedures, alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent
* Able to read, understand, and complete the questionnaires
Exclusion Criteria:
* Has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASEâ„¢
* Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies (including rituximab), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid…