Skip to main content
Clinical Trials/EUCTR2011-006002-27-FR
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

Sponsor
CHU de Bordeaux

Similar Trials