Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBVAXPRO · 1 trial · 1 indication
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
| Arm | Type | Description |
|---|---|---|
| HBVAXPRO™ | EXPERIMENTAL | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Name | Type | Description |
|---|---|---|
| HBVAXPRO™ | BIOLOGICAL | Single 0.5 mL intramuscular dose |
Inclusion Criteria: * Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator. * Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxe...
HBVAXPRO is a vaccine used for Hepatitis B. It is a monoclonal antibody modality developed by Merck & Company, Inc. (MRK). The drug is currently in Phase 3 clinical development as an investigational product, meaning it is not yet approved and is still being studied.
HBVAXPRO is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the vaccine for Hepatitis B. As of the latest data, HBVAXPRO is in Phase 3 development.
HBVAXPRO is in Phase 3 clinical development. It is an investigational vaccine for Hepatitis B and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with 207 participants enrolled.
HBVAXPRO is associated with one completed Phase 3 clinical trial, NCT04490499, titled "A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)." The trial enrolled 207 participants in Finland, with healthy volunteers aged 8 years and older.
HBVAXPRO is not the same as Vaxelis. The clinical trial NCT04490499 is a challenge study that evaluates HBVAXPRO after previous vaccination with Vaxelis. HBVAXPRO is a separate vaccine for Hepatitis B, developed by Merck & Company, Inc.