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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00343421 | Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers | PHASE3 | COMPLETED | 588 | — | — | Jul 1, 2006 | Jun 1, 2009 | Jun 3, 2016 | 2 | France, Poland |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | PEDIACEL co-administered with Prevenar |
| Group 2 | ACTIVE_COMPARATOR | Infanrix-IPV+Hib co-administered with Prevenar |
| Name | Type | Description |
|---|---|---|
| PEDIACEL® and Prevenar® | BIOLOGICAL | 0.5 mL each, IM (opposite thigh) |
| Infanrix®-IPV+Hib and Prevenar® | BIOLOGICAL | 0.5 mL each, IM (opposite thigh) |
Inclusion Criteria: * Infants 55 to 75 days old, inclusive on the day of first vaccination * Born at full term of pregnancy (\> 37 weeks) * Informed consent form signed by the parent(s) or the legal guardian * Parents or the legal guardian able to read and write in the local language * Parent(s) or...