Trial | NCT01761435  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    499
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:

Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose.
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).
Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels.
Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients.
Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.
Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study.
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.
Study Started
Oct 31
2012
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
May 01
2015
Estimate

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.

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.

Influenza vaccine Active Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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).
No Results Posted