Approval Probability
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Also known as DAPTACEL®. (DTaP), IPOL®., and ActHIB®., DAPTACEL., IPOL., and 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, IPOL, and ActHIB are combination vaccines used for immunization against diphtheria, polio, and pertussis. They are administered to infants starting at 42 days of age. These vaccines help prevent infectious diseases caused by these pathogens.
Sanofi (ticker: SNY) develops DAPTACEL, IPOL, and ActHIB. These are combination vaccines used in pediatric immunization schedules to protect against diphtheria, polio, and pertussis.
DAPTACEL, IPOL, and ActHIB are in Phase 3 clinical development. They are investigational combination vaccines, not yet approved for general use. A Phase 3 trial has been completed to evaluate their safety and immune response.
DAPTACEL, IPOL, and ActHIB have one completed Phase 3 trial, NCT00255047, titled "Safety and Immune Response of Different Pediatric Combination Vaccines." This trial enrolled 2,167 participants in the United States, including healthy infants aged 42 days and older.
DAPTACEL, IPOL, and ActHIB are three separate vaccines that are often administered together as a combination regimen. DAPTACEL protects against diphtheria, tetanus, and pertussis; IPOL protects against polio; and ActHIB protects against Haemophilus influenzae type b. They are not a single combined vaccine product.