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Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 · 2 trials · 3 indications
| Name | Type | Description |
|---|---|---|
| Prophylaxis: Diphtheria, tetanus and pertussis | BIOLOGICAL | - |
| Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 | BIOLOGICAL | - |
Inclusion Criteria: \- Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age Exclusion Criteria: * Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the a...
It is a prophylactic vaccine candidate developed by GSK plc (ticker GSK) for protection against diphtheria, tetanus, pertussis and poliovirus types 1, 2 and 3. It is an investigational product in Phase 3 development and has been studied in a completed Phase 2 trial in the United States.
It is intended for prophylaxis, meaning prevention, of diphtheria, tetanus, pertussis and poliovirus types 1, 2 and 3. The related Phase 3 study evaluated a Tdap booster in children and adolescents, and the Phase 2 study assessed immune response and safety against diphtheria, acellular pertussis and tetanus.
GSK plc, which trades under the ticker GSK, is the developer of this prophylactic vaccine candidate. GSK Biologicals conducted the clinical studies of the DTaP-IPV and Tdap formulations described in the trial records.
It is in Phase 3 development. One Phase 3 trial, NCT00263679, has been completed, and a Phase 2 trial, NCT00263692, has also been completed. It is an investigational product and is not described as approved.
Two completed trials are recorded: NCT00263692, a Phase 2 comparison of a DTaP-IPV candidate vaccine with DTaP and IPV given separately, enrolling 401 participants in the United States, and NCT00263679, a Phase 3 Tdap booster study enrolling 321 participants in Germany.