clinical trial to evaluating efficacy of a double dose of seasonal flu vaccine compared to single dose for prevention of influenza in solid organ transplant recipients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003243-21-ES

Enrollment

462

Registered

2011-08-09

Start date

2011-10-17

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

seasonal influenza prophylaxis in trasplant receipiens MedDRA version: 14.0 Level: LLT Classification code 10021829 Term: Infection in solid organ transplant recipients System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: GRIPAVAC Product Name: GRIPAVAC Product Code: NA Pharmaceutical Form: Solution for injection in pre-filled syringe Current Sponsor code: NYMC X-179A Other descriptive name: A/CALIFORNIA/7/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. solid organ transplant receipation. 2. 16 years or older. 3. More than 30 days after transplantation. 4. Negative pregnancy test for women of childbearing age 5. The patient must give informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 46 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: 1. No written informed consent. 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: to study whether two doses of flu vaccine work better than single dose in transplant recipiens;Secondary Objective: 1. To assess the humoral immune response to one and two doses of seasonal flu vaccine through the levels of neutralizing antibodies in serum. 2. To determine the specific cellular immune response caused after one and two doses of seasonal flu vaccine through the stimulation of cells in memory vito specific influenza virus A and B. 3. To evaluate the clinical efficacy of seasonal flu vaccine in the recipient of solid organ transplantation. 4. To assess the humoral and cellular immunity in the long term (one year) of the seasonal flu vaccine. 5. To establish the effectiveness of one and two doses of seasonal flu vaccine in groups with lower response to the vaccine. (Liver failure, use of mTOR inhibitors, first 6 months after transplantation). 6. To determine the safety of two doses of seasonal flu vaccine.;Primary end point(s): Difference in seroconversion rates in both groups;Timepoint(s) of evaluation of this end point: at 5 and 10 weeks of the first vaccine dose	—

Measure

Time frame

Main Objective: to study whether two doses of flu vaccine work better than single dose in transplant recipiens;Secondary Objective: 1. To assess the humoral immune response to one and two doses of seasonal flu vaccine through the levels of neutralizing antibodies in serum. 2. To determine the specific cellular immune response caused after one and two doses of seasonal flu vaccine through the stimulation of cells in memory vito specific influenza virus A and B. 3. To evaluate the clinical efficacy of seasonal flu vaccine in the recipient of solid organ transplantation. 4. To assess the humoral and cellular immunity in the long term (one year) of the seasonal flu vaccine. 5. To establish the effectiveness of one and two doses of seasonal flu vaccine in groups with lower response to the vaccine. (Liver failure, use of mTOR inhibitors, first 6 months after transplantation). 6. To determine the safety of two doses of seasonal flu vaccine.;Primary end point(s): Difference in seroconversion rates in both groups;Timepoint(s) of evaluation of this end point: at 5 and 10 weeks of the first vaccine dose

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Geometric average postvaccination antibody titers and rate of increase between pre-and post-vaccination geometric mean, post-vaccination seroprotection rate (or percentage of individuals with a titer ? 1 / 40 as measured by RIH). 2. Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection. 3. Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR. Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability.;Timepoint(s) of evaluation of this end point: At selection time, 5 weeks, 10 weeks and 1 year.	—

Measure

Time frame

Secondary end point(s): 1. Geometric average postvaccination antibody titers and rate of increase between pre-and post-vaccination geometric mean, post-vaccination seroprotection rate (or percentage of individuals with a titer ? 1 / 40 as measured by RIH). 2. Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection. 3. Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR. Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability.;Timepoint(s) of evaluation of this end point: At selection time, 5 weeks, 10 weeks and 1 year.

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Countries

Spain

Contacts

Public Contactrepresentante

Fundación Pública Andaluza Progreso y Salud

gestionensayosclinicos.fps@juntadeandalucia.es34955040450

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026