Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
Randomized, multicenter, open label trial to compare safety and efficacy of two doses
 stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.
The purposes of this study are:

 1. Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a
 single dose.

 2. Determine the specific cellular immune response produced after the first and second
 vaccine doses of seasonal flu vaccine by in vitro stimulation of specific memory cells
 (A and B flu viruses).

 3. Evaluate the humoral immune response produced after one dose vs two doses of seasonal
 flu vaccine by the measure of serum antibody levels.

 4. Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant
 recipients.

 5. Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.

 6. Characterize the genetic expression profile of immune response after the flu vaccine in
 solid organ transplant recipients by means of a genetic sub-study.

 7. Characterize the flu vaccine effect (one dose and two doses) through the antibody
 anti-HLA(human leukocyte antigen), and its influence on the rejection rate in solid
 organ transplant recipients, by means of immunologic sub-study.
Inclusion Criteria:

 1. Solid organ transplant recipient.

 2. 16 years or older.

 3. More than 30 days after transplantation.

 4. Negative pregnancy test for women of childbearing potential

 5. The patient must give informed consent

 Exclusion Criteria:

 1. No written informed consent.

 2. Acute rejection within 15 days prior to vaccination.

 3. Pregnancy.

 4. Hypersensitivity to the active substance, any of the excipients and waste, for
 example: eggs, egg albumin, chicken proteins.

 5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).