Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diphtheria and Tetanus toxoids adsorbed · 1 trial · 3 indications
Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.7 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but \< 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
| Arm | Type | Description |
|---|---|---|
| SP306 Group | EXPERIMENTAL | Participants randomized to receive SP306 vaccine intramuscularly |
| DT Group | ACTIVE_COMPARATOR | Participants randomized to receive DT vaccine subcutaneously |
| Name | Type | Description |
|---|---|---|
| Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed | BIOLOGICAL | 0.5 mL, intramuscularly. |
| Diphtheria and Tetanus toxoids adsorbed | BIOLOGICAL | 0.1 mL, Subcutaneously |
Inclusion Criteria: * Aged 11 or 12 years and considered healthy on the day of inclusion * Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively * Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e....
Diphtheria and Tetanus toxoids adsorbed is a vaccine used for immunization against tetanus and diphtheria. It is being studied in Japanese adolescents aged 11 to 12 years for the prevention of tetanus, diphtheria, and pertussis. The drug is currently in Phase 3 clinical development.
Sanofi (ticker: SNY) is developing Diphtheria and Tetanus toxoids adsorbed. The company is conducting a Phase 3 clinical trial for this vaccine in Japan.
Diphtheria and Tetanus toxoids adsorbed is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Diphtheria and Tetanus toxoids adsorbed has one completed Phase 3 trial, NCT02089347, titled 'Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old'. The trial enrolled 534 participants in Japan and was active-controlled and double-blind.
Yes, Diphtheria and Tetanus toxoids adsorbed is also known as SP306. The clinical trial NCT02089347 refers to the drug as SP306, and it is being studied for immunization against tetanus, diphtheria, and pertussis.