Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis B vaccine · 1 trial · 5 indications
Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.
Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay
Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7. |
| Study Group 2 | ACTIVE_COMPARATOR | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6. |
| Name | Type | Description |
|---|---|---|
| Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV | BIOLOGICAL | 0.5 mL, Intramuscular |
| Hepatitis B vaccine | BIOLOGICAL | 0.5 ml, Intramuscular |
Inclusion Criteria: * Age 11 years and \< 14 years of age. * Signed, witnessed and dated informed consent that is obtained prior to the first study intervention. * Judged to be in good health on the basis of reported medical history. * Plans to remain in the study area for the length of the trial. ...
Hepatitis B vaccine is used for pertussis, tetanus, diphtheria, poliomyelitis, and hepatitis B. It is being studied in a Phase 2 clinical trial as a combination vaccine for these infectious diseases.
Sanofi (ticker: SNY) is developing the Hepatitis B vaccine. The company is conducting clinical research on this vaccine for infectious disease indications.
Hepatitis B vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Hepatitis B vaccine has one completed Phase 2 trial, NCT02040636, which studied tetanus and diphtheria toxoids adsorbed combined with component pertussis vaccine and inactivated poliomyelitis. The trial enrolled 277 participants in Canada.
Yes, Hepatitis B vaccine is classified as a monoclonal antibody modality. It is being studied in an active-controlled, randomized Phase 2 trial that is not double-blind.