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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00255047 | Safety and Immune Response of Different Pediatric Combination Vaccines. | PHASE3 | COMPLETED | 2,167 | — | — | Nov 1, 2005 | Feb 1, 2009 | Feb 14, 2014 | 36 | United States |
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 |
| 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 |
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...