Status:
UNKNOWN
9-valent HPV Vaccine in Postpartum Women
Lead Sponsor:
Augusta University
Conditions:
Human Papilloma Virus
Eligibility:
FEMALE
16-45 years
Phase:
PHASE4
Brief Summary
This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.
Detailed Description
Women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent HPV vaccine. For clarification, women who are pregnant are eligible to sig...
Eligibility Criteria
Inclusion
- 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
- Has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™
- 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 therapy, has recently (within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. The use of inhaled, nasal, or topical steroids are considered eligible for the study
- Has received any immune globulin product (including RhoGAM™) or other blood- derived product within 3 months prior to Day 1 vaccination or plans to receive such product during the study
- Has received a marketed HPV vaccine
- Has had a fever of \> 100° within 24-hour period prior to the Day 1 vaccination
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04311528
Start Date
April 1 2020
End Date
December 31 2021
Last Update
March 17 2020
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