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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01086904
Eligibility Criteria:
Inclusion criteria:
* Age \> 18 and \< 60 years old
* Signed information consent
* Social security coverage
* Renal transplantation \> 6 months with a creatinine clearance \> 20 ml/mn
* Stable renal function defined as serum creatinine variation \< 20 % for the last three months
* Receiving a triple immunosuppression regimen including steroids, Calcineurine inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil or mycophenolic acid)
* Regular follow-up
For child bearing aged female:
* Negative urinary HCG
* Contraception during the first three months of the study
Exclusion criteria:
* Poor renal function defined as creatinine clairance \< 20 ml/mn
* Unstable renal function defined as serum creatinine variations \> 20 % during the last 3 months
* Cellular or humoral acute rejection episode during the last 3 months before inclusion
* Known HIV, HBV or HCV infection
* Other vaccine administered during the last 3 weeks before inclusion or scheduled in the month after the second vaccine injection
* Known allergy to egg proteins or to one the vaccine compounds
* Severe adverse events after prior administration of any influenza vaccine
* Multiple sclerosis
* Past history of Guillain Barre syndrome
* Fever at inclusion
* H1N1 influenza episode with positive virological tests during the last 6 months
* Contact with people infected with H1N1 influenza during the week prior to inclusion
* Cancer requiring radiotherapy or chemotherapy during the last 6 months
* Blood transfusion during the last 3 months
* Pregnancy during the last 3 months
* No follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01086904
Study Brief:
Protocol Section:
NCT01086904