Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination

Summary

Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.

Conditions

• Infection in Solid Organ Transplant Recipients

Interventions

BIOLOGICAL

Influenza vaccine

Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions : A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose. The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline.

Sponsors & Collaborators

• Spanish Network for Research in Infectious Diseases

  collaborator OTHER

• Fundación Pública Andaluza Progreso y Salud

  lead OTHER

Principal Investigators

• Julian De la Torre Cisneros, PhD · COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA

• Francisco López Medrano, PhD · Hospital Universitario 12 de Octubre

• Patricia Muñoz García, PhD · HOSPITAL GENERAL GREGORIO MARAÑÓN

• Jesús Fortun Abete, PhD · Hospital Universitario Ramon y Cajal

• Joán Gavaldà Santapau, PhD · HOSPITALS VALL D'HEBRON

• Jordi Carratalá Fernández, PhD · Hospital Universitari de Bellvitge

• Asunción Moreno Camacho, PhD · Hospital Clinic i provincial de Barcelona

• José Miguel Montejo Baranda, PhD · HOSPITAL UNIVERSITARIO DE CRUCES

• Marino Blanes Julia, PhD · Hospital Universitario La Fe

• Alejandro Suarez Benjumea, PhD · COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA

• Carmen Fariñas Álvarez, PhD · Hospital Universitario Marqués de Valdecilla

• Maria Elisa Cordero Matia, PhD · Hospital Universitario Virgen del Rocio

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2014-01-31

Completion

2014-01-31

Countries

• Spain

Study Locations