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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01298102

Enrollment

185

Registered

2011-02-17

Start date

2009-10-31

Completion date

2010-03-31

Last updated

2011-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreased Immunologic Activity [PE], Influenza, Rejection

Keywords

kidney, transplantation, haemodialysis, vaccination, influenza H1N1 2009

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.

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.

Interventions

BIOLOGICALInfluenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

intramuscular injection of 1 dose vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls	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

Measure	Time frame	Description
to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination	follow-up 6 months	To measure the Anti-HLA and anti-MICA antibodies with luminex-test

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026