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Also known as dTpa
dTpa vaccine · 2 trials · 1 indication
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...
The dTpa vaccine is used for immunization against diphtheria, tetanus, and acellular pertussis (whooping cough). It is being studied in healthy Japanese adolescents aged 11 to under 13 years and in healthy pregnant women aged 18 years and older. The vaccine is currently in Phase 3 clinical development.
The dTpa vaccine is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting Phase 3 clinical trials to evaluate the vaccine's immune response and safety in Japanese populations.
The dTpa vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. Two Phase 3 trials are currently active, one in adolescents and one in pregnant women, both conducted in Japan.
The dTpa vaccine is being studied in two Phase 3 trials. NCT07596173 evaluates immune response and safety in healthy Japanese adolescents aged 11 to under 13 years, with 90 participants. NCT07596199 evaluates the same in healthy Japanese pregnant women aged 18 years and older, with 100 participants. Both trials are active.
Yes, the dTpa vaccine is also known as dTpa. The name dTpa refers to the combined diphtheria, tetanus, and acellular pertussis vaccine. In clinical trials, it is referred to as a combined vaccine against these three diseases.