Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Henogen HB vaccine |
|
| 2 | Active Comparator | Fendrix vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henogen HBV vaccine | Biological | 20µg, Month 0, 2 and 6 |
| |
| FENDRIX |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs seroprotection rate at Month 2. | Month 0 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Months 0, 1, 2, 3, 6 and 7 | |
| Anti-HBs seroprotection rates for all subjects. | Months 0, 1, 2, 3, 6 and 7 | |
| Anti-HBs seropositivity rates for all subjects |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Tielemans, MD, PhD | ULB Hôpital Erasme Département de Néphrologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O.L.Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| RHMS La Madeleine ATH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
20 µg,Months 0, 1, 2 and 6 |
|
| Months 0, 1, 2, 3, 6 and 7 |
| Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. | Months 0, 1, 2, 3, 6 and 7 |
| Anti-HBs geometric mean concentrations calculated for all subjects. | Months 0, 1, 2, 3, 6 and 7 |
| Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. | Months 0 and 7 |
| Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. | Month 0 and 7 |
| Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. | Month 0, 1, 2, 3, 6 and 7 |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. | Month 0, 1, 2, 3, 6 and 7 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. | Month 0 to 7 |
| Ath |
| 7800 |
| Belgium |
| RHMS Clinique Louis Caty Baudour | Baudour | 7331 | Belgium |
| AZ -VUB Dienst Nefrologie | Brussels | 1090 | Belgium |
| Cliniques universitaires Saint Luc | Brussels | 1200 | Belgium |
| CHU Brugmann (site V Horta) Service de néphrologie | Brussels | B-1020 | Belgium |
| ULB Hôpital Erasme Département de Néphrologie | Brussels | Belgium |
| CHU Hôpital civil de | Charleroi | 6000 | Belgium |
| UZ AntwerpenDienst nefrologie | Edegem | B-2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| UZ Gasthuisberg Leuven Nierziekten | Leuven | 3000 | Belgium |
| CHU Andre VESALE | Montigny-le-Tilleul | 6110 | Belgium |
| RHMS TournayService de néphrologie | Tournai | 7500 | Belgium |
| Dept. of Heamodialysis Hospital JihlavaVrchlického | Jihlava | 59586 33 | Czechia |
| Regional Hospital Liberec | Liberec | 46063 | Czechia |
| Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | Ostrava - Poruba | 1790708 52 | Czechia |
| Dept. of Internal Medicine StrahovSermirska 5 | Prague | 169 00 | Czechia |
| Masaryk´s Hospital Socialni pece 3316/12A | Ústí nad Labem | 401 13 | Czechia |
| St. Rókus Hospital | Budapest | 1085 | Hungary |
| St. István Hospital | Budapest | 1096 | Hungary |
| Petz Aladár Teaching Hospital Vasvári | Győr | H-9023 | Hungary |
| Pest County Flór Ferenc Hospital | Kistarcsa | 2143 | Hungary |
| Vas and Szombathely County Markusovszky Hospital | Szombathely | 9700 | Hungary |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C515207 | Fendrix |
Not provided
Not provided
Not provided