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Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01298102
First received: February 16, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.


Condition Intervention Phase
Decreased Immunologic Activity [PE]
Influenza
Rejection
 Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls [ Time Frame: one month post-vaccination ] [ Designated as safety issue: Yes ]
    measures of anti-A/H1N1 antibodies with a method of microneutralizing test (seroneutralization) to follow-up the secondary effects of the vaccine and follow-up of renal function in renal transplanted patients.


Secondary Outcome Measures:
  • to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination [ Time Frame: follow-up 6 months ] [ Designated as safety issue: Yes ]
    To measure the Anti-HLA and anti-MICA antibodies with luminex-test


Enrollment: 185
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: influenza vaccine
Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls
 Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine
Other Name: Pandemrix

Detailed Description:

The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.

The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult patients
  2. Haemodialyzed patients
  3. Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria:

  1. No pneumonia or severe infection during 1 month before vaccination
  2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298102

Locations
Belgium
Hospital Erasme
Brussels, Brabant, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Study Director: Daniel Abramowicz, PhD Hospital Erasme
  More Information

Publications:

Responsible Party: Broeders Nilufer, Hospital Erasme
ClinicalTrials.gov Identifier: NCT01298102     History of Changes
Other Study ID Numbers: Etude 2009/INT044
Study First Received: February 16, 2011
Last Updated: February 16, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Erasme University Hospital:
kidney
transplantation
haemodialysis
vaccination
influenza H1N1 2009

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013