Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02089347 | Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old | PHASE3 | COMPLETED | 534 | — | — | Mar 1, 2014 | Mar 1, 2015 | May 30, 2017 | 19 | Japan |
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....