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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01463683 | Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) | PHASE3 | COMPLETED | 722 | — | — | Nov 29, 2011 | Nov 6, 2012 | Jul 18, 2018 | - | — |
Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.
Participants were evaluated for injection-site adverse events using MedDRA version 15.1
Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).
| Arm | Type | Description |
|---|---|---|
| V232-2XP SC | EXPERIMENTAL | 2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 |
| V232-1XP SC | ACTIVE_COMPARATOR | 1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 |
| V232-2XP IM | EXPERIMENTAL | 2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| Name | Type | Description |
|---|---|---|
| 2XP HEPTAVAX™-II SC | BIOLOGICAL | - |
| 1XP HEPTAVAX™-II SC | BIOLOGICAL | - |
| 2XP HEPTAVAX™-II IM | BIOLOGICAL | - |
Inclusion Criteria: To receive the first study vaccination, Participants should meet all inclusion criteria. * Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main ...