Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients (Transfluvac)

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