Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V232 Modified Process Hepatitis B Vaccine: Lot A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| V232 Modified Process Hepatitis B Vaccine: Lot A | EXPERIMENTAL | Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
| V232 Modified Process Hepatitis B Vaccine: Lot B | EXPERIMENTAL | Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
| V232 Modified Process Hepatitis B Vaccine: Lot C | EXPERIMENTAL | Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
| V232 Current Process Hepatitis B Vaccine | ACTIVE_COMPARATOR | Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. |
| Name | Type | Description |
|---|---|---|
| V232 Modified Process Hepatitis B Vaccine: Lot A | BIOLOGICAL | - |
| V232 Modified Process Hepatitis B Vaccine: Lot B | BIOLOGICAL | - |
| V232 Modified Process Hepatitis B Vaccine: Lot C | BIOLOGICAL | - |
| V232 Current Process Hepatitis B Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * In general good health * Female participants have a negative pregnancy test just prior to vaccination on Day 1 Exclusion Criteria: * History of Hepatitis B Infection or vaccination * Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., alumin...
V232 Modified Process Hepatitis B Vaccine: Lot A is an investigational vaccine being studied for the prevention of Hepatitis B Infection. It is a recombinant hepatitis B vaccine manufactured with an upgraded production process. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
V232 Modified Process Hepatitis B Vaccine: Lot A is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety, tolerability, and immunogenicity of this recombinant hepatitis B vaccine.
V232 Modified Process Hepatitis B Vaccine: Lot A is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for preventing Hepatitis B Infection.
V232 Modified Process Hepatitis B Vaccine: Lot A has one completed Phase 3 clinical trial registered as NCT00489099, titled 'A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054).' The trial enrolled 860 participants aged 20 years and older.
Yes, V232 Modified Process Hepatitis B Vaccine: Lot A is a recombinant hepatitis B vaccine. It is manufactured using an upgraded production process compared to earlier versions. The vaccine is being studied for its ability to prevent Hepatitis B Infection and is currently in Phase 3 clinical development.