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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01086904
• Date of registration: 16/11/2009
• Prospective Registration: No
• Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Public title: Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients Transfluvac
• Scientific title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
• Date of first enrolment: November 2009
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01086904
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Transplant Recipients

Immunosuppression

Intervention(s)

Biological: inactivated non adjuvanted pandemic H1N1 vaccine

Primary Outcome(s)

Specific humoral response 21 days after each administration Seroprotection and seroconversion rates [Time Frame: after each vaccination and at 6 months]

Secondary Outcome(s)

Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc [Time Frame: 6 months]

Secondary ID(s)

2009-016659-23

C09-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi Pasteur MSD