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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00697775 | Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents | PHASE2 | COMPLETED | 200 | — | — | Mar 1, 1998 | - | Jun 16, 2008 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | HBV-MPL Formulation A at months 0 and 6 |
| Group B | EXPERIMENTAL | HBV-MPL Formulation B at months 0 and 6 |
| Group C | EXPERIMENTAL | HBV-MPL Formulation A at month 0 and Engerix™-B at month 6 |
| Group D | ACTIVE_COMPARATOR | Engerix™-B at months 0, 1, 6 |
| Name | Type | Description |
|---|---|---|
| HBV-MPL vaccine Formulation A | BIOLOGICAL | Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection |
| HBV-MPL vaccine Formulation B | BIOLOGICAL | 2-dose intramuscular injection |
| Engerix™-B | BIOLOGICAL | Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection |
Inclusion Criteria: * Age: between 11 and 15 years at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guardians of the subject and ...