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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT01687192
Eligibility Criteria:
Inclusion Criteria:
* Female gender
* Age ≥ 9 years and \< 18 years
* Weight ≥ 25 kg
* Solid organ transplantation: kidney, liver, heart, lung, intestinal or combined transplant; or systemic lupus erythematosus or other systemic immune disease
* Transplantation or diagnosis of lupus or diagnosis of systemic immune disease since more than 6 months
* Immunosuppressant treatment by anti-metabolites or calcineurin inhibitors, with or without associated corticosteroids
* Minimum required period of 3 months considered as stable after transplantation or without relapse of lupus according to physician evaluation
* In case of sexual activity (assessed by auto-declaration): onset less than one year before inclusion
* Written informed consent signed by the investigator and the legal representatives of the patient, and assent by the patient
Exclusion Criteria:
* Male gender
* Pregnancy
* Age \< 9 years or ≥ 18 years
* Previous HPV vaccination
* Immunosuppressive treatment by anti-TNF (adalimumab, etanercept, infliximab) or monoclonal antibodies (rituximab, anakinra, abatacept) during the last 3 months
* Active malignancy
* Active opportunistic infection
* HIV infection
* Concurrent clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
9 Years
Maximum Age:
18 Years
Study:
NCT01687192
Study Brief:
Protocol Section:
NCT01687192