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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07596173 | A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years | PHASE3 | NOT YET_RECRUITING | 85 | — | — | Jun 29, 2026 | Oct 14, 2026 | May 19, 2026 | - | — |
| NCT07596199 | A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women | PHASE3 | NOT YET_RECRUITING | 95 | — | — | Jun 29, 2026 | Jan 20, 2027 | May 19, 2026 | - | — |
Seropositivity is defined as antibody concentrations (anti-PT, anti-FHA and anti-PRN) are greater than or equal to the assessed assay cut-offs. The considered cut-off values are: anti-PT: 2.693 International Units per milliliter (IU/mL), anti-FHA: 2.046 IU/mL, anti-PRN: 2.187 IU/mL, as measured by Enzyme-Linked Immunosorbent assay (ELISA).
Seroprotection is defined as anti-diphtheria and anti- tetanus antibody concentrations being \>=0.1 IU/mL as measured by ELISA.
Seropositivity is defined as antibody concentrations (anti-PT, anti-FHA and anti-PRN) are greater than or equal to the assessed assay cut-offs. The considered cut-off values are: anti-PT: 2.693 International Units per milliliter (IU/mL), anti-FHA: 2.046 IU/mL, anti-PRN: 2.187 IU/mL, as measured by Enzyme-Linked Immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| dTpa Group | EXPERIMENTAL | Participants aged 11 to less than (\<) 13 years receive the dTpa vaccine at Day 1. |
| Name | Type | Description |
|---|---|---|
| dTpa vaccine | BIOLOGICAL | Combined reduced antigen content diphtheria, tetanus and acellular pertussis (dTpa) vaccine administered at Day 1. |
| dTpa | BIOLOGICAL | 1 dose of dTpa vaccine is administered intramuscularly. |
Inclusion Criteria: * Participants and/or participants' parent(s)/ Legally acceptable representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Physical or digital informed assent obtained from the participant prior to perfor...