Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2XP HEPTAVAX-II · 1 trial · 1 indication
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 ...
2XP HEPTAVAX-II is an investigational monoclonal antibody being developed for the prevention of Hepatitis B. It is currently in Phase 3 clinical development and has been studied in a completed trial involving 722 participants. The drug is being developed by Merck & Company, Inc. (MRK).
2XP HEPTAVAX-II is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for use in Hepatitis B, an infectious disease. The drug is in Phase 3 clinical development and is being developed by Merck & Company, Inc. (MRK).
2XP HEPTAVAX-II is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is an investigational monoclonal antibody in Phase 3 clinical development for Hepatitis B. It has been studied in a completed Phase 3 trial with 722 participants.
2XP HEPTAVAX-II is in Phase 3 clinical development. It is an investigational monoclonal antibody for Hepatitis B and is not yet approved. The drug has completed one Phase 3 trial, NCT01463683, which enrolled 722 participants. It is being developed by Merck & Company, Inc. (MRK).
2XP HEPTAVAX-II has been studied in one completed Phase 3 clinical trial, NCT01463683, titled "Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)." The trial enrolled 722 participants and was randomized, double-blind, and active-controlled. The drug is being developed by Merck & Company, Inc. (MRK).