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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00258895 | Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® | PHASE3 | COMPLETED | 649 | — | — | Mar 1, 2005 | Apr 1, 2007 | Apr 14, 2016 | 22 | United States |
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 ...