Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diphteria, tetanus, and Acellular Pertussis vaccine · 2 trials · 5 indications
Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine | BIOLOGICAL | 0.5 mL, IM |
| Diphteria, tetanus, and Acellular Pertussis vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 42 to 56 days inclusive on the day of inclusion * Born at full term pregnancy (\> 37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial proced...