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 recombinant hepatitis B vaccine developed by Merck & Company, Inc. It is designed to prevent hepatitis B infection and was manufactured using an upgraded production process. The vaccine has been studied in a Phase 3 clinical trial.
V232 Modified Process Hepatitis B Vaccine: Lot A is intended for the prevention of hepatitis B infection. It is a vaccine candidate studied in healthy volunteers aged 20 years and older. The Phase 3 trial evaluated its safety, tolerability, and immunogenicity.
V232 Modified Process Hepatitis B Vaccine: Lot A is made by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the developer of this recombinant hepatitis B vaccine candidate.
V232 Modified Process Hepatitis B Vaccine: Lot A is in Phase 3 clinical development. The Phase 3 trial has been completed. It is an investigational vaccine and has not been approved by the FDA.
V232 Modified Process Hepatitis B Vaccine: Lot A has been studied in one Phase 3 clinical trial, NCT00489099. This completed trial enrolled 860 participants and evaluated the safety, tolerability, and immunogenicity of the vaccine in healthy volunteers. It was randomized, double-blind, and active-controlled.