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

February 16, 2011 updated by: Erasme University Hospital

Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brabant
      • Brussels, Brabant, Belgium, 1070
        • Hospital Erasme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Pandemrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
one month post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To measure the Anti-HLA and anti-MICA antibodies with luminex-test
follow-up 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Study Director: Daniel Abramowicz, PhD, Hospital Erasme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Etude 2009/INT044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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