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Trial record 6 of 28 for:    pandemrix AND influenza vaccine

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

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ClinicalTrials.gov Identifier: NCT01298102
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Erasme University Hospital

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 17, 2011
Last Update Posted Date February 17, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients
Official Title  ICMJE Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Decreased Immunologic Activity [PE]
  • Influenza
  • Rejection
Intervention  ICMJE Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine
Other Name: Pandemrix
Study Arms  ICMJE Experimental: influenza vaccine
Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls
Intervention: Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2011)
185
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298102
Other Study ID Numbers  ICMJE Etude 2009/INT044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Broeders Nilufer, Hospital Erasme
Study Sponsor  ICMJE Erasme University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Abramowicz, PhD Hospital Erasme
PRS Account Erasme University Hospital
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP