NCT01761435

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
499

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

December 13, 2012

Last Update Submit

April 30, 2015

Conditions

Infection in Solid Organ Transplant Recipients

Keywords

InfluenzaSolid Organ Transplant Recipients

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rates

    Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers).

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Secondary Outcomes (6)

  • Postvaccination antibody titers

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose.

  • Safety.

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose

  • Efficacy

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose

  • Antibody anti-HLA

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose

  • Cellular response

    At 5, 10, 15 weeks, and 12 months after the first vaccine dose

  • +1 more secondary outcomes

Study Arms (2)

Influenza vaccine, second administration after 5 weeks

EXPERIMENTAL

Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one.

Biological: Influenza vaccine

Influenza vaccine

ACTIVE COMPARATOR

Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline.

Biological: Influenza vaccine

Interventions

Influenza vaccineBIOLOGICAL

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 vaccineInfluenza vaccine, second administration after 5 weeks

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Solid organ transplant recipient.
  • years or older.
  • More than 30 days after transplantation.
  • Negative pregnancy test for women of childbearing potential
  • The patient must give informed consent

You may not qualify if:

  • No written informed consent.
  • Acute rejection within 15 days prior to vaccination.
  • Pregnancy.
  • Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
  • History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Clinic Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Barcelona, Spain

Location

Hospital Universitario de Cruces

Bilbao, Bilbao, Spain

Location

Hospital Universitario Masqués de Valdecilla

Santander, Bilbao, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital General Gregorio Marañon

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Madrid, Spain

Location

Hospital Vall d'Hebron

Madrid, Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Hospital Regional Virgen de la Macarena

Seville, Sevilla, Spain

Location

Hospital la Fe de Valencia

Valencia, Valencia, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25228850DERIVED

  • 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.

    PMID: 25168918DERIVED

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Julian De la Torre Cisneros, PhD

    COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA

    PRINCIPAL INVESTIGATOR

  • Francisco López Medrano, PhD

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

  • Patricia Muñoz García, PhD

    HOSPITAL GENERAL GREGORIO MARAÑÓN

    PRINCIPAL INVESTIGATOR

  • Jesús Fortun Abete, PhD

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

  • Joán Gavaldà Santapau, PhD

    HOSPITALS VALL D'HEBRON

    PRINCIPAL INVESTIGATOR

  • Jordi Carratalá Fernández, PhD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Asunción Moreno Camacho, PhD

    Hospital Clinic i provincial de Barcelona

    PRINCIPAL INVESTIGATOR

  • José Miguel Montejo Baranda, PhD

    HOSPITAL UNIVERSITARIO DE CRUCES

    PRINCIPAL INVESTIGATOR

  • Marino Blanes Julia, PhD

    Hospital Universitario La Fe

    PRINCIPAL INVESTIGATOR

  • Alejandro Suarez Benjumea, PhD

    COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA

    PRINCIPAL INVESTIGATOR

  • Carmen Fariñas Álvarez, PhD

    Hospital Universitario Marqués de Valdecilla

    PRINCIPAL INVESTIGATOR

  • Maria Elisa Cordero Matia, PhD

    Hospital Universitario Virgen del Rocio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

January 4, 2013

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

ES(12)