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Also known as ADACEL POLIO
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...
The TdcP-IPV vaccine is an investigational combination vaccine developed by Sanofi for protection against diphtheria, tetanus, pertussis, and poliomyelitis. It is designed to prompt immune responses against these four diseases in a single formulation. The vaccine is in Phase 3 clinical development and has been studied in healthy volunteers.
The TdcP-IPV vaccine is being developed for immunization against diphtheria, tetanus, pertussis, and poliomyelitis. Its clinical program has focused on these four infectious diseases, with diphtheria as a primary indication. It is intended for use in healthy individuals, including children from six years of age.
Sanofi, which trades under the ticker SNY, is the developer of the TdcP-IPV vaccine. Sanofi is a global pharmaceutical company with an established vaccines business. The company conducted the Phase 3 trial of this candidate in Taiwan.
The TdcP-IPV vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA for any indication.
The TdcP-IPV vaccine has been evaluated in one completed Phase 3 trial, NCT00797511, titled Immunogenicity and Safety of Adacel Polio Vaccine. The trial enrolled 132 healthy volunteers aged six years and older in Taiwan and studied diphtheria, tetanus, pertussis, and poliomyelitis. It was an uncontrolled study.