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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02117934 | Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine | PHASE3 | COMPLETED | 8,374 | — | — | Apr 1, 2014 | Oct 1, 2015 | Mar 20, 2019 | 40 | United States |
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
| Arm | Type | Description |
|---|---|---|
| HEPLISAV | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV. |
| Engerix-B | ACTIVE_COMPARATOR | 1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B. |
| Name | Type | Description |
|---|---|---|
| HEPLISAV | BIOLOGICAL | Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24 |
| Engerix-B | BIOLOGICAL | Intramuscular injections at Week 0, Week 4, and Week 24 |
A subject must meet all of the following criteria to be eligible for the trial: Inclusion Criteria: * Be 18-70 years of age, inclusive * Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study * If a woman is of childbearing potential, she...