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
|Condition or disease||Intervention/treatment||Phase|
|Decreased Immunologic Activity [PE] Influenza Rejection||Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: influenza vaccine
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)
intramuscular injection of 1 dose vaccine
Other Name: Pandemrix
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298102
|Brussels, Brabant, Belgium, 1070|
|Study Director:||Daniel Abramowicz, PhD||Hospital Erasme|