Skip to main content
OpenTrials
Completed

NCT Number: NCT01298102

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Decreased Immunologic Activity [PE] Behavior Infections Influenza Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Rejection Rejection, Psychology Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Erasme

Brussels, Brabant, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients
  • Haemodialyzed patients
  • Renal transplant recipients who have stable renal function for the last 3 months

Exclusion criteria

  • No pneumonia or severe infection during 1 month before vaccination
  • No Ivig (intravenous immunoglobulins) treatment during the last 3 months

Treatment and study plan

Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

Biological

intramuscular injection of 1 dose vaccine

Other names: Pandemrix

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2011
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.