Influenza Vaccination in Immunocompromized Patients

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Abbott
MSD Chibret Switzerland
Solvay Pharmaceuticals
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00783380
First received: October 30, 2008
Last updated: October 31, 2008
Last verified: October 2008

October 30, 2008
October 31, 2008
October 2005
July 2006   (final data collection date for primary outcome measure)
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40) [ Time Frame: >60 Wochen ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783380 on ClinicalTrials.gov Archive Site
  • Reactogenicity in rheumatologic patients by disease specific scores [ Time Frame: Six weeks after vaccination ] [ Designated as safety issue: Yes ]
  • Immediate side effects at time of application of vaccination [ Time Frame: Minutes after vaccination ] [ Designated as safety issue: Yes ]
  • Side effects after vaccination [ Time Frame: First week after vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influenza Vaccination in Immunocompromized Patients
Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.

The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Immunosuppression
  • Biological: Virosomal influenza vaccine
    Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
  • Biological: Subunit influenza vaccine
    Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
  • Experimental: Virosomal influenza vaccine
    Intervention: Biological: Virosomal influenza vaccine
  • Active Comparator: Subunit influenza vaccine
    Intervention: Biological: Subunit influenza vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
March 2008
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult outpatients treated at the Inselspital Bern for:
  • HIV infection
  • rheumatologic diseases and receiving immunosuppressive drugs
  • kidney transplant recipients
  • undergoing hemodialysis or continuous ambulatory peritoneal dialysis
  • written informed consent

Exclusion Criteria:

  • Allergy to egg proteins
  • Former adverse reactions to prior vaccination
  • Febrile conditions at the time of study inclusion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00783380
KEK No 805 (EK 151/03)
No
Evison John, MD Oberarzt, Universitätsklinik für Infektiologie, PKT 2B, Inselspital, 3011 Bern, Switzerland
University Hospital Inselspital, Berne
  • Boehringer Ingelheim
  • Abbott
  • MSD Chibret Switzerland
  • Solvay Pharmaceuticals
Principal Investigator: John M Evison, MD Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland
University Hospital Inselspital, Berne
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP