Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
NCT ID: NCT01761435
Last Updated: 2015-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
499 participants
INTERVENTIONAL
2012-10-31
2014-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Influenza vaccine, second administration after 5 weeks
Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one.
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.
Influenza vaccine
Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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).
16 Years
ALL
No
Sponsors
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Spanish Network for Research in Infectious Diseases
OTHER
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Julian De la Torre Cisneros, PhD
Role: PRINCIPAL_INVESTIGATOR
COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA
Francisco López Medrano, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre
Patricia Muñoz García, PhD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL GENERAL GREGORIO MARAÑÓN
Jesús Fortun Abete, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramon y Cajal
Joán Gavaldà Santapau, PhD
Role: PRINCIPAL_INVESTIGATOR
HOSPITALS VALL D'HEBRON
Jordi Carratalá Fernández, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Asunción Moreno Camacho, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
José Miguel Montejo Baranda, PhD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL UNIVERSITARIO DE CRUCES
Marino Blanes Julia, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Alejandro Suarez Benjumea, PhD
Role: PRINCIPAL_INVESTIGATOR
COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA
Carmen Fariñas Álvarez, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Marqués de Valdecilla
Maria Elisa Cordero Matia, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen del Rocio
Locations
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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
Hospital Regional Virgen de la Macarena
Seville, Sevilla, Spain
Hospital la Fe de Valencia
Valencia, Valencia, Spain
Countries
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References
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Demetz G, Laux M, Scherhag A, Hoekstra T, Suttorp MM, Dekker F, Roest M, Marcus-Kalish M, Mittelman M, Ott I. The influence of Erythropoietin on platelet activation, thrombin generation and FVII/active FVII in patients with AMI. Thromb J. 2014 Aug 28;12:18. doi: 10.1186/1477-9560-12-18. eCollection 2014.
Martinez-Atienza J, Rosso-Fernandez C, Roca C, Aydillo TA, Gavalda J, Moreno A, Montejo JM, Torre-Cisneros J, Farinas MC, Fortun J, Sabe N, Munoz P, Blanes-Julia M, Suarez-Benjumea A, Lopez-Medrano F, Perez-Romero P, Cordero E; TRANSGRIPE 1-2 Study Group. Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2014 Aug 28;15:338. doi: 10.1186/1745-6215-15-338.
Related Links
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The Spanish Network for the Research in Infectious Diseases (REIPI) is based in research groups of high standards and professional level. REIPI´s aim is to generate scientific knowledge in the field of the infectious diseases, in areas ranging from basic
Other Identifiers
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TraNsgripe1-2
Identifier Type: -
Identifier Source: org_study_id
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