NCT01298102

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Decreased Immunologic Activity [PE]
• Influenza
• Rejection

Interventions

Type	Name	Description
BIOLOGICAL	Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)	intramuscular injection of 1 dose vaccine

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2011-02-17
• Last updated: 2011-02-17

Locations

1 site across 1 country: Belgium