Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00662870 | Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine | PHASE3 | COMPLETED | 1,941 | — | — | May 1, 2001 | Jan 1, 2004 | Jan 31, 2012 | 26 | United States |
| 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...