A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.

PHASE3CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Hepatitis B
Interventions
BIOLOGICAL

HB-AS02V vaccine

HB-AS02V (20µg HBsAg) will be administered at Month 0

BIOLOGICAL

HBVAXPRO vaccine

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

Trial Locations (28)

1200

Cliniques universitaires Saint Luc, Brussels

3000

UZ Gasthuisberg Leuven Nierziekten, Leuven

6000

CHU Hôpital civil de, Charleroi

6110

CHU Andre VESALE, Montigny-le-Tilleul

7100

CHU Tivoli, La Louvière

7331

RHMS Clinique Louis Caty Baudour, Baudour

7500

RHMS TournayService de néphrologie, Tournai

7800

RHMS La Madeleine ATH, Ath

9000

UZ Gent, Ghent

9300

O.L.Vrouwziekenhuis Aalst, Aalst

9700

Vas and Szombathely County Markusovszky Hospital, Szombathely

46063

Regional Hospital Liberec, Liberec

B-1020

CHU Brugmann (site V Horta) Service de néphrologie, Brussels

Unknown

ULB Hôpital Erasme Département de Néphrologie, Brussels

B-2650

UZ AntwerpenDienst nefrologie, Edegem

581500 05

Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska, Hradec Králové

59586 33

Hospital JihlavaVrchlického, Jihlava

6775 20

Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova, Olomouc

1790708 52

Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic, Ostrava - Poruba

44532 03

Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska, Pardubice

142 00

Fresenius Medical Care - DS Prague 4, Prague

169 00

Dept. of Internal Medicine StrahovSermirska 5, Prague

1863356 01

Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska, Sokolov

.H-4012

University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department, Debrecen

H-3300

Markhot Ferenc County HospitalFresenius Dialysis Center Baktai, Eger

H-2500

Vaszary Kolos HospitalFresenius Dialysis Center, Esztergom

H-9023

Petz Aladár Teaching Hospital Vasvári, Győr

H-3000

Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan ., Hatvan

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Henogen

INDUSTRY