Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dTpa · 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 a combined vaccine against diphtheria, tetanus, and acellular pertussis. It is being developed by GSK plc (ticker: GSK) and is in Phase 3 clinical development. The vaccine is studied in healthy populations, including pregnant women and adolescents, for protection against these three bacterial infections.
The dTpa vaccine is used for immunization against diphtheria, tetanus, and acellular pertussis. Clinical studies are evaluating its immune response and safety in healthy Japanese pregnant women and in healthy Japanese adolescents aged 11 to under 13 years. It is intended to protect against these three infectious diseases.
GSK plc, which trades under the ticker GSK, is the developer of the dTpa vaccine. The company is running Phase 3 clinical trials of the combined diphtheria, tetanus, and acellular pertussis vaccine, including studies in Japanese pregnant women and Japanese adolescents.
The dTpa vaccine is in Phase 3 clinical development. It is investigational and has not been approved. Two Phase 3 trials are registered, one active and not recruiting and one completed, with a combined enrollment of 190 participants across both studies.
The dTpa vaccine is being studied in two Phase 3 trials. NCT07596199 evaluates immune response and safety in healthy Japanese pregnant women and is active but not recruiting. NCT07596173 evaluated immune response and safety in healthy Japanese adolescents aged 11 to under 13 years and is completed. Both trials are in Japan.
Yes, dTpa is another name for the dTpa vaccine. The abbreviation stands for diphtheria, tetanus, and acellular pertussis, the three diseases the combined vaccine targets. Searches for dTpa and dTpa vaccine refer to the same GSK Phase 3 product.