Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TdcP-IPV vaccine · 1 trial · 4 indications
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Study Group | EXPERIMENTAL | Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0 |
| Name | Type | Description |
|---|---|---|
| TdcP-IPV vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 6 to 8 years on the day of inclusion * Informed consent form signed by the parent(s) or another legally acceptable representative * Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures * Written documentation of complete pri...
TdcP-IPV vaccine is used for immunization against diphtheria, as well as tetanus, pertussis, and poliomyelitis. It is a combination vaccine being developed by Sanofi for the prevention of these infectious diseases.
Sanofi (ticker: SNY) is developing the TdcP-IPV vaccine. The vaccine is currently in Phase 3 clinical development for the prevention of diphtheria and other infectious diseases.
TdcP-IPV vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
TdcP-IPV vaccine has one completed Phase 3 trial, NCT00797511, titled 'Immunogenicity and Safety of Adacel Polio Vaccine'. This trial enrolled 132 participants in Taiwan and evaluated the vaccine in healthy volunteers aged 6 years and older.
TdcP-IPV vaccine is also known as Adacel Polio. The completed clinical trial NCT00797511 used the name Adacel Polio Vaccine to refer to this vaccine candidate.