A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Hepatitis B
Interventions
BIOLOGICAL

Henogen HBV vaccine

20µg, Month 0, 2 and 6

BIOLOGICAL

FENDRIX

20 µg,Months 0, 1, 2 and 6

Trial Locations (24)

1085

St. Rókus Hospital, Budapest

1090

AZ -VUB Dienst Nefrologie, Brussels

1096

St. István Hospital, Budapest

1200

Cliniques universitaires Saint Luc, Brussels

2143

Pest County Flór Ferenc Hospital, Kistarcsa

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

59586 33

Dept. of Heamodialysis Hospital JihlavaVrchlického, Jihlava

1790708 52

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

169 00

Dept. of Internal Medicine StrahovSermirska 5, Prague

401 13

Masaryk´s Hospital Socialni pece 3316/12A, Ústí nad Labem

H-9023

Petz Aladár Teaching Hospital Vasvári, Győr

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Henogen

INDUSTRY