Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine 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....
Tdap is a combined vaccine used to protect against tetanus, diphtheria, and pertussis (whooping cough). It contains tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis antigens adsorbed onto an adjuvant. It is given to boost immunity against these three bacterial infections.
Sanofi develops and manufactures this Tdap vaccine, which is studied under the code SP306. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company conducted the clinical development program for this vaccine candidate.
This Tdap vaccine has completed a Phase 3 clinical trial. It is an investigational product studied in a late-stage trial rather than a newly approved product in this dataset. The Phase 3 study has been completed, and no active trials are currently listed.
The Tdap vaccine was studied in NCT02089347, a Phase 3 trial 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 has been completed.
NCT02089347 was a randomized, double-blind, active-controlled Phase 3 trial. It enrolled 534 healthy adolescent volunteers aged 11 years and older in Japan and compared intramuscular SP306 with subcutaneous DT. The study covered tetanus, diphtheria, and pertussis and has been completed.