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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT01092195
Eligibility Criteria:
* INCLUSION CRITERIA:
Female stem cell transplant recipient at least 90 days post stem cell transplant
OR
Female stem cell transplant recipient at least 90 days post HSCT and on immunosuppression
OR
The matched female stem cell transplant donor for an included stem cell transplant recipient
OR
Healthy female subject
Age greater than or equal to 18 years and less than or equal to 50 years
EXCLUSION CRITERIA:
Vaccine Recipient:
Obvious HPV condyloma or obvious severe dysplasia (greater than or equal to CIN II) warranting treatment
History of severe adverse reaction to any components (yeast, eggs, monosodium glutamate or neomycin) of the quadrivalent HPV vaccine.
Untreated or persistent life-threatening infections not controlled by current treatment
Uncontrolled chronic GVHD i.e. highly active eGVHD requiring immediate intervention
Pregnant or breast feeding or unwilling to be abstinent or practice effective contraception during the study period (note: patients who have been rendered infertile with total body irradiation are eligible)
Enrollment in another vaccine clinical trial during the study period
Enrollment of healthy volunteer in a drug clinical trial during the study period
Inability to comprehend the investigational nature of the study and provide informed consent\<TAB\>
Prior Gardasil or other HPV vaccination
Persistent or recurrent malignancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01092195
Study Brief:
Protocol Section:
NCT01092195