Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00697866 | Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control | PHASE3 | COMPLETED | 951 | — | — | Aug 1, 2000 | - | Sep 16, 2016 | - | — |
| NCT00697554 | Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age | PHASE3 | COMPLETED | 93 | — | — | Jan 1, 2000 | - | Sep 9, 2016 | - | — |
| NCT00698061 | Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y | PHASE3 | COMPLETED | 145 | — | — | Nov 1, 1999 | May 1, 2001 | May 30, 2017 | - | — |
| NCT00696917 | Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y | PHASE3 | COMPLETED | 1,303 | — | — | Apr 1, 1999 | - | Jun 13, 2008 | 7 | Australia, Czechia +5 |
| NCT00697749 | Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype | PHASE3 | COMPLETED | 230 | — | — | Apr 1, 1999 | Jan 1, 2000 | Sep 16, 2016 | - | — |
| NCT00697216 | Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs). | PHASE3 | COMPLETED | 340 | — | — | Mar 1, 1997 | - | Jun 13, 2008 | 2 | Belgium, Denmark |
| NCT00699231 | Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 1992 | Dec 1, 1992 | Jun 17, 2008 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | HBV-MPL Lot A |
| Group B | EXPERIMENTAL | HBV-MPL Lot B |
| Group C | EXPERIMENTAL | HBV-MPL Lot C |
| Group D | ACTIVE_COMPARATOR | Engerix™-B |
| Group A1 | ACTIVE_COMPARATOR | Non-responders to vaccination after at least 7 previous injections |
| Group A2 | EXPERIMENTAL | Non-responders to vaccination after at least 7 previous injections |
| Group B1 | ACTIVE_COMPARATOR | Vaccine-responders requiring a booster dose |
| Group B2 | EXPERIMENTAL | Vaccine-responders requiring a booster dose |
| Group C1 | ACTIVE_COMPARATOR | Volunteers participating in the hospital's vaccination program |
| Group C2 | EXPERIMENTAL | Volunteers participating in the hospital's vaccination program |
| Group D1 | ACTIVE_COMPARATOR | Unvaccinated haemodialysis patients |
| Group D2 | EXPERIMENTAL | Unvaccinated haemodialysis patients |
| Name | Type | Description |
|---|---|---|
| HBV-MPL vaccine 208129 | BIOLOGICAL | 3 consecutive lots; 3-dose intramuscular injection |
| Engerix™-B | BIOLOGICAL | 3-dose intramuscular injection |
Inclusion Criteria: * A male or female between, and including, 15 and 50 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable * Free of obvious health problems as established by medical...