Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
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ClinicalTrials.gov Identifier: NCT00776750 |
Recruitment Status :
Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
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Condition or disease | Intervention/treatment | Phase |
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Hemodialysis Renal Transplantation | Biological: trivalent split influenza vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 407 participants |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients |
Study Start Date : | September 2003 |
Primary Completion Date : | May 2004 |
Study Completion Date : | May 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: influenza vaccination
All participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004.
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Biological: trivalent split influenza vaccine
standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection |
- Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
- Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- maintenance hemodialysis patients or
- renal transplant recipients (beyond month 3 after transplantation)
Exclusion Criteria:
- patients with known allergy to chicken proteins

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): NCT00776750
Belgium | |
University Hospital Leuven | |
Leuven, Belgium, 3000 |
Principal Investigator: | Yves Vanrenterghem, MD, PhD | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00776750 |
Other Study ID Numbers: |
ML2394 |
First Posted: | October 21, 2008 Key Record Dates |
Last Update Posted: | October 21, 2008 |
Last Verified: | October 2008 |