Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Euvax B: Hepatitis B vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Hexaxim® Group | EXPERIMENTAL | Subjects that received Hexaxim® in Study A3L12 |
| Infanrix® hexa Group | EXPERIMENTAL | Subjects that received Infanrix® hexa in Study A3L12 |
| Name | Type | Description |
|---|---|---|
| Euvax B®: Hepatitis B vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Informed consent form signed by subject's parent/legally acceptable representative * Assent form signed by subject * Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures * Receipt of primary vaccin...
Euvax B is a hepatitis B vaccine used for the prevention of hepatitis B infection. It is indicated for hepatitis B, an infectious disease affecting the liver. The vaccine is designed to generate an immune response against the hepatitis B virus.
Euvax B is developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the development and clinical testing of this hepatitis B vaccine.
Euvax B is in Phase 3 clinical development. It is an investigational hepatitis B vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Euvax B has one completed Phase 3 clinical trial registered under NCT02697474. This trial, conducted in Thailand, enrolled 150 participants aged 9 to 10 years to assess anti-hepatitis B antibodies following vaccination at birth and with a hexavalent vaccine.
Euvax B is classified as a monoclonal antibody modality, though it functions as a vaccine. In the context of the clinical trial data, it is described as a hepatitis B vaccine, and its mechanism involves eliciting an immune response against the hepatitis B virus.