Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
NCT ID: NCT00291954
Last Updated: 2008-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
257 participants
INTERVENTIONAL
2006-03-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Henogen hepatitis B vaccine
HB-AS02V
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
2
HBVAXPRO hepatitis B vaccine
HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
Interventions
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HB-AS02V
HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from the subject/ from the parent or guardian of the subject.
* Seronegative for anti-HBc antibodies and for HBsAg at screening.
* Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
* Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
* The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
* Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.
Exclusion Criteria
* Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
15 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Henogen
INDUSTRY
Responsible Party
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Henogen
Principal Investigators
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Christian Tielemans, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ULB Hôpital Erasme Département de Néphrologie
Locations
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O.L.Vrouwziekenhuis Aalst
Aalst, , Belgium
RHMS La Madeleine ATH
Ath, , Belgium
RHMS Clinique Louis Caty Baudour
Baudour, , Belgium
Cliniques universitaires Saint Luc
Brussels, , Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, , Belgium
ULB Hôpital Erasme Département de Néphrologie
Brussels, , Belgium
CHU Hôpital civil de
Charleroi, , Belgium
UZ AntwerpenDienst nefrologie
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
CHU Tivoli
La Louvière, , Belgium
UZ Gasthuisberg Leuven Nierziekten
Leuven, , Belgium
CHU Andre VESALE
Montigny-le-Tilleul, , Belgium
RHMS TournayService de néphrologie
Tournai, , Belgium
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
Hradec Králové, , Czechia
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, , Czechia
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
Olomouc, , Czechia
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, , Czechia
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
Pardubice, , Czechia
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
Sokolov, , Czechia
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
Debrecen, , Hungary
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
Eger, , Hungary
Vaszary Kolos HospitalFresenius Dialysis Center
Esztergom, , Hungary
Petz Aladár Teaching Hospital Vasvári
Győr, , Hungary
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
Hatvan, , Hungary
Zala County HospitalII. Medical Department Nephrology Zrinyi
Zalaegerszeg, , Hungary
Countries
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Other Identifiers
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HN017/HBV-003 (105762)
Identifier Type: -
Identifier Source: org_study_id
NCT00671762
Identifier Type: -
Identifier Source: nct_alias