![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Henogen GlaxoSmithKline |
---|---|
Information provided by: | Henogen |
ClinicalTrials.gov Identifier: | NCT00291980 |
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Biological: HB-AS02V vaccine Biological: HBVAXPRO vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody. |
Enrollment: | 185 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
HB-AS02V vaccine
|
Biological: HB-AS02V vaccine
HB-AS02V (20µg HBsAg) will be administered at Month 0
|
2: Active Comparator
HBVAXPRO vaccine
|
Biological: HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
|
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of these visits.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
CHU Andre VESALE | |
Montigny le tilleul, Belgium, 6110 | |
CHU Brugmann (site V Horta) Service de néphrologie | |
Bruxelles, Belgium, B-1020 | |
CHU Hôpital civil de | |
Charleroi, Belgium, 6000 | |
RHMS Clinique Louis Caty Baudour | |
Baudour, Belgium, 7331 | |
Cliniques universitaires Saint Luc | |
Bruxelles, Belgium, 1200 | |
O.L.Vrouwziekenhuis Aalst | |
Aalst, Belgium, 9300 | |
CHU Tivoli | |
La Louvière, Belgium, 7100 | |
RHMS La Madeleine ATH | |
ATH, Belgium, 7800 | |
RHMS TournayService de néphrologie | |
Tournai, Belgium, 7500 | |
ULB Hôpital Erasme Département de Néphrologie | |
Bruxelles, Belgium | |
UZ AntwerpenDienst nefrologie | |
Edegem, Belgium, B-2650 | |
UZ Gasthuisberg Leuven Nierziekten | |
Leuven, Belgium, 3000 | |
UZ Gent | |
Gent, Belgium, 9000 | |
Czech Republic | |
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska | |
Hradec Kralove, Czech Republic, 581500 05 | |
Dept. of Internal Medicine StrahovSermirska 5 | |
Prague, Czech Republic, 169 00 | |
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova | |
Olomouc, Czech Republic, 6775 20 | |
Fresenius Medical Care - DS Prague 4 | |
Prague, Czech Republic, 142 00 | |
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska | |
Pardubice, Czech Republic, 44532 03 | |
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | |
Ostrava - Poruba, Czech Republic, 1790708 52 | |
Hospital JihlavaVrchlického | |
Jihlava, Czech Republic, 59586 33 | |
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska | |
Sokolov, Czech Republic, 1863356 01 | |
Regional Hospital Liberec | |
Liberec, Czech Republic, 46063 | |
Hungary | |
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan . | |
Hatvan, Hungary, H-3000 | |
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai | |
Eger, Hungary, H-3300 | |
Petz Aladár Teaching Hospital Vasvári | |
Győr, Hungary, H-9023 | |
Vaszary Kolos HospitalFresenius Dialysis Center | |
Esztergom, Hungary, H-2500 | |
Vas and Szombathely County Markusovszky Hospital | |
Szombathely, Hungary, 9700 | |
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department | |
Debrecen, Hungary, .H-4012 |
Principal Investigator: | Christian Tielemans, MD, PhD | ULB Hôpital Erasme Département de Néphrologie |
Responsible Party: | Henogen ( Sophie Houard CSO ) |
Study ID Numbers: | HN018/HBV-004 (105754) |
Study First Received: | February 14, 2006 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00291980 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Dialysis Pre-dialysis Hepatitis B vaccine Prophylaxis hepatitis B infection |
Virus Diseases Hepatitis Antibodies Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Immunoglobulins |
Hepadnaviridae Infections |