EUCTR2011-006002-27-FRActive, not recruitingNot Applicable
Multicentre trial evaluating the immunogenicity of HPV vaccination in girls on immunosuppressive therapy. - PRIMAVERA
CHU de Bordeaux0 sitesStarted: January 5, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Female gender
- •- Age = 9 years
- •- 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 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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