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Randomized, Comparative and Prospective Clinical Trial Evaluating Efficacy and Safety of a Dose of Seasonal Flu Vaccine Compared to Two Doses of Vaccine for Prevention of Influenza in Solid Organ Transplant Recipients
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Clinic Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Bilbao, Spain
Hospital Universitario Masqués de Valdecilla
Santander, Bilbao, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Hospital General Gregorio Marañon
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
Hospital Vall d'Hebron
Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Start Date
October 1, 2012
Primary Completion Date
January 1, 2014
Completion Date
January 1, 2014
Last Updated
May 1, 2015
499
ACTUAL participants
Influenza vaccine
BIOLOGICAL
Lead Sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Data Source & Attribution
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