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

PHASE3CompletedINTERVENTIONAL
Enrollment

499

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

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."

Trial Locations (12)

41013

Hospital Universitario Virgen del Rocío, Seville

Unknown

Hospital Clinic Provincial de Barcelona, Barcelona

Hospital Universitario de Bellvitge, Barcelona

Hospital Universitario de Cruces, Bilbao

Hospital Universitario Masqués de Valdecilla, Santander

Hospital Universitario Reina Sofía, Córdoba

Hospital General Gregorio Marañon, Madrid

Hospital Ramón y Cajal, Madrid

Hospital Universitario 12 Octubre, Madrid

Hospital Vall d'Hebron, Madrid

Hospital Regional Virgen de la Macarena, Seville

Hospital la Fe de Valencia, Valencia

All Listed Sponsors
collaborator

Spanish Network for Research in Infectious Diseases

OTHER

lead

Fundación Pública Andaluza Progreso y Salud

OTHER

NCT01761435 - Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination | Biotech Hunter | Biotech Hunter