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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01298102
Other study ID # Etude 2009/INT044
Secondary ID
Status Completed
Phase Phase 4
First received February 16, 2011
Last updated February 16, 2011
Start date October 2009
Est. completion date March 2010

Study information

Verified date June 2010
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine

Locations

Country Name City State
Belgium Hospital Erasme Brussels Brabant

Sponsors (1)

Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls 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 Yes
Secondary to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination To measure the Anti-HLA and anti-MICA antibodies with luminex-test follow-up 6 months Yes
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