MedTrace Logo

Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients

NCT01781871 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2017-10-05

No results posted yet for this study

Summary

Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.

Conditions

  • Kidney Transplantation
  • Liver Transplantation

Interventions

BIOLOGICAL

Prevenar13

Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.

BIOLOGICAL

Pneumovax

0.5ml Pneumovax injected intramuscularly at day 1.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Veli-Jukka Anttila, MD,PhD,Docent · HUCH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-10-04
Completion
2017-10-04

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781871 on ClinicalTrials.gov