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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Influenza; Decreased Immunologic Activity [PE]; Rejection

Treatments: Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

Study type: Interventional

Funder types: Other

Identifiers

NCT01298102

Etude 2009/INT044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 1 patient group

influenza vaccine

Experimental group

Description:

Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls

Treatment:

Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)