Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Tra… (NCT01086904) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
France122 participantsStarted 2009-11
Plain-language summary
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 …
What they're measuring
1
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates