Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAPTACEL: DTaP · 1 trial · 3 indications
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Booster response calculation: If pre-Dose 5 titer \< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
| Arm | Type | Description |
|---|---|---|
| DAPTACEL Primed | EXPERIMENTAL | Participants received Daptacel in Study P3T06. |
| Pentacel Primed | EXPERIMENTAL | Participants received Pentacel in Study P3T06 |
| Name | Type | Description |
|---|---|---|
| DAPTACEL®: DTaP | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged ≥ 4 and \< 7 years from date of birth at the time of study vaccination * Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB ...
DAPTACEL: DTaP is used for the prevention of diphtheria, tetanus, and pertussis. It is a vaccine being developed by Sanofi for the infectious disease indication of diphtheria. The drug is currently in Phase 3 clinical development.
Sanofi (ticker: SNY) is the developer of DAPTACEL: DTaP. The company is conducting clinical trials for this vaccine, which is being studied for the prevention of diphtheria, tetanus, and pertussis.
DAPTACEL: DTaP 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, with no active trials currently ongoing.
DAPTACEL: DTaP has one completed Phase 3 trial, NCT00258895, which studied its safety and immunogenicity as a 5th dose in children aged 4 to 6 years after four doses of Pentacel or DAPTACEL. The trial enrolled 649 participants in the United States.
Yes, DAPTACEL: DTaP is classified as a monoclonal antibody modality. It is being developed for the prevention of diphtheria, tetanus, and pertussis, and is currently in Phase 3 clinical trials.