Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients
NCT ID: NCT01298102
Last Updated: 2011-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
185 participants
INTERVENTIONAL
2009-10-31
2010-03-31
Brief Summary
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Detailed Description
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The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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influenza vaccine
Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls
Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine
Interventions
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Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Haemodialyzed patients
3. Renal transplant recipients who have stable renal function for the last 3 months
Exclusion Criteria
2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months
18 Years
ALL
Yes
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Hospital Erasme
Principal Investigators
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Daniel Abramowicz, PhD
Role: STUDY_DIRECTOR
Hospital Erasme
Locations
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Hospital Erasme
Brussels, Brabant, Belgium
Countries
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References
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Candon S, Thervet E, Lebon P, Suberbielle C, Zuber J, Lima C, Charron D, Legendre C, Chatenoud L. Humoral and cellular immune responses after influenza vaccination in kidney transplant recipients. Am J Transplant. 2009 Oct;9(10):2346-54. doi: 10.1111/j.1600-6143.2009.02787.x. Epub 2009 Jul 28.
Other Identifiers
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Etude 2009/INT044
Identifier Type: -
Identifier Source: org_study_id
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