Approval Probability
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Adjusted LOA
ML Risk
Also known as IPOL®, ActHIB®
DAPTACEL · 2 trials · 6 indications
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
| Arm | Type | Description |
|---|---|---|
| Study Group 1: DAPTACEL®, ActHIB®, and IPOL® | EXPERIMENTAL | Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively |
| Study Group 2: Pentacel® | EXPERIMENTAL | Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively |
| Study Group 3: DTaP-IPV and ActHIB® | EXPERIMENTAL | Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively |
| Study Group 4: Pentacel® | EXPERIMENTAL | Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively |
| 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®. (DTaP), IPOL®., and ActHIB®. | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pentacel®: DTaP-IPV/Hib combined | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV and ActHIB® | BIOLOGICAL | 0.5 mL, Intramuscular |
| 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: * Aged ≥ 42 days and ≤ 89 days on the day of inclusion * Born at full term of pregnancy (≥ 36 weeks) * Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure * Vaccination with a hepatitis B vaccine at l...
DAPTACEL is a vaccine used to help protect against diphtheria, along with tetanus and whooping cough (pertussis). It is a pediatric combination vaccine, and the clinical trials supporting it enrolled healthy infants from 42 days of age. It is given as part of routine childhood immunization schedules.
DAPTACEL is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer and manufacturer of the vaccine, which is part of its pediatric combination vaccine portfolio.
DAPTACEL has completed Phase 3 clinical development. Two Phase 3 trials are recorded, both completed, with no active trials ongoing. The studies together enrolled 4,108 participants and were randomized, double-blind, and active-controlled.
DAPTACEL has been studied in two completed Phase 3 trials. NCT00662870 evaluated safety, immunogenicity, and lot comparability when DAPTACEL was given with other recommended vaccines, enrolling 1,941 participants. NCT00255047 assessed safety and immune response of different pediatric combination vaccines, enrolling 2,167 participants. Both were conducted in the United States.
No. DAPTACEL is a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine. IPOL is a polio vaccine and ActHIB is a Haemophilus influenzae type b vaccine. These are separate products that may be referenced together because they are sometimes administered alongside DAPTACEL in pediatric immunization regimens.
DAPTACEL is a vaccine that targets diphtheria, tetanus, and acellular pertussis. It works by stimulating the immune system to develop protection against the toxins and components of these bacteria. Its target class is described as cell-based, reflecting the acellular pertussis component of the formulation.