Comparison of the efficacy of pneumococcal and tetanus vaccination between hemodialysis patients and renal tranpslant recipients treated with Mycophenolic acid(VACC-IR) study. - VACC-IR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001806-94-BE

Enrollment

Registered

2006-05-02

Start date

2006-05-22

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Patients on dialysis and waiting for renal transplant and renal translanted patients

Interventions

Product Name: Prevenar Pharmaceutical Form: Injection* INN or Proposed INN: vaccin pneumoccique Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 0.4-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1- adult patient aged between 18 and 75 years 2- patients transplanted between 1 and 5 years previously; with a kidney graft only, or dialyzed patients registred on the waiting list for a kidney transplant (or with ongoing registration) 3- renal transplant recipients treated with mycophenolic acid and a calcineurin inhibitor for at least 3 months 4- renal transplant recipients who did not experience a rejection episode during the last 6 months, and have stable renal fonctuion for the last 5 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1- no pneumonia or severe infection during 1 mont before vaccination 2- no pneumococcal or tetanos vaccination during the last 5 years 3-no Ivig (intravenous immunoglobulins) treatment during the last 3 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare renal transplant reicipients and dialyzed patients for the proportion developing an antibocy response to 23-valent pneumococcal polysaccharid vaccine;Secondary Objective: To compare renal transplant recipients and dialyzed patients for the proportion developing an antibody response to the tetanus toxoid vaccine To evaluate the proportion of renal transplant reicipients and dialyzed patients who develop an adequate response to the heptavalent proteic-conjugate pneumoccal vaccine in case of unresponsiveness to the 23-valent polysaccharide vaccine;Primary end point(s): To compare the antibody responses to vaccines to vaccines in stable renal transplant recipient treated with Mycophenolic acid, as compared to dialyzed patients listed for transplantation and awaiting for renal graft	—

Measure

Time frame

Main Objective: To compare renal transplant reicipients and dialyzed patients for the proportion developing an antibocy response to 23-valent pneumococcal polysaccharid vaccine;Secondary Objective: To compare renal transplant recipients and dialyzed patients for the proportion developing an antibody response to the tetanus toxoid vaccine To evaluate the proportion of renal transplant reicipients and dialyzed patients who develop an adequate response to the heptavalent proteic-conjugate pneumoccal vaccine in case of unresponsiveness to the 23-valent polysaccharide vaccine;Primary end point(s): To compare the antibody responses to vaccines to vaccines in stable renal transplant recipient treated with Mycophenolic acid, as compared to dialyzed patients listed for transplantation and awaiting for renal graft

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Countries

Belgium

Outcome results

None listed

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