Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pentacel: DTaP-IPV/Hib · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| DAPTACEL Lot 1 | EXPERIMENTAL | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1 |
| DAPTACEL Lot 2 | EXPERIMENTAL | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2 |
| DAPTACEL Lot 3 | EXPERIMENTAL | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3 |
| Pentacel | ACTIVE_COMPARATOR | Participants receiving Pentacel vaccine |
| Name | Type | Description |
|---|---|---|
| DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pentacel: DTaP-IPV/Hib | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Healthy infants 2 months of age. * Infants with at least 37 weeks of gestation at delivery. * Signed informed consent from parent or guardian. * Able to attend the scheduled visits and to comply with the study procedure. * Subjects must have received the first dose of hepatit...
Pentacel: DTaP-IPV/Hib is a combination vaccine used for the prevention of diphtheria, tetanus, whooping cough (pertussis), polio, and Haemophilus influenzae type b disease. It is indicated for use in infants and young children, typically administered as a series of doses starting at 42 days of age.
Pentacel: DTaP-IPV/Hib is developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the research, development, and potential commercialization of this vaccine.
Pentacel: DTaP-IPV/Hib is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Pentacel: DTaP-IPV/Hib has one completed Phase 3 clinical trial with the identifier NCT00662870. This study, titled 'Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine,' enrolled 1,941 participants in the United States and was a randomized, double-blind, active-controlled trial.
Pentacel: DTaP-IPV/Hib is a combination vaccine that includes components similar to DAPTACEL, which is also a Sanofi product. The clinical trial NCT00662870 specifically studied DAPTACEL when administered with other recommended vaccines, and Pentacel: DTaP-IPV/Hib is a related combination vaccine formulation.