Multicentre trial evaluating the immunogenicity of HPV vaccination in girls on immunosuppressive therapy. - PRIMAVERA

CHU de Bordeaux0 个研究点开始时间: 2012年1月5日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

CHU de Bordeaux