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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00435812 | Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine | PHASE3 | COMPLETED | 2,428 | — | — | Dec 1, 2006 | Mar 1, 2008 | Mar 20, 2019 | 18 | Canada, Germany |
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
| Arm | Type | Description |
|---|---|---|
| HEPLISAV and/or Placebo | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
| Engerix-B | ACTIVE_COMPARATOR | 1.0 mL Engerix-B |
| Name | Type | Description |
|---|---|---|
| HEPLISAV and/or Placebo | BIOLOGICAL | Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24 |
| Engerix-B | BIOLOGICAL | Intramuscular (IM) injections on Week 0, Week 4, and Week 24 |
Inclusion Criteria: * Willing and able to give written informed consent * Is serum negative for HBV antibodies Exclusion Criteria: * Women who are pregnant or breastfeeding * Any previous HBV infection * Previous vaccination with any HBV vaccine (1 or more doses) * Any autoimmune disease * Receiv...