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Trial record 6 of 28 for:    pandemrix AND influenza vaccine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298102
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : February 17, 2011
Information provided by:
Erasme University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Decreased Immunologic Activity [PE] Influenza Rejection Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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 Name: Pandemrix

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01298102

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Hospital Erasme
Brussels, Brabant, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
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Study Director: Daniel Abramowicz, PhD Hospital Erasme
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Responsible Party: Broeders Nilufer, Hospital Erasme Identifier: NCT01298102    
Other Study ID Numbers: Etude 2009/INT044
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: June 2010
Keywords provided by Erasme University Hospital:
influenza H1N1 2009
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases