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

NCT01298102 | Completed Phase 4 DMC

• 1 other identifier: Etude 2009/INT044
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Decreased Immunologic Activity [PE]; Influenza; Rejection

Keywords

kidney; transplantation; haemodialysis; vaccination; influenza H1N1 2009

Outcome Measures

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

  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

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

  follow-up 6 months

Study Arms (1)

influenza vaccine

EXPERIMENTAL

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

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

Interventions

Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix) BIOLOGICAL

intramuscular injection of 1 dose vaccine

Also known as: Pandemrix

influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hospital Erasme

Brussels, Brabant, 1070, Belgium

Location

Related 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.

  PMID: 19656126 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Rejection, Psychology

Interventions

pandemrix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Social Behavior; Behavior

Study Officials

• Daniel Abramowicz, PhD

  Hospital Erasme

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 17, 2011

Record last verified: 2010-06

Locations

BE (1)