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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192478 | Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524 | PHASE1 | COMPLETED | 217 | — | — | Feb 1, 2004 | Aug 1, 2006 | Jul 28, 2008 | 3 | Argentina, Chile |
| NCT00192465 | Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults | PHASE1 | COMPLETED | 30 | — | — | Nov 1, 2003 | Nov 1, 2004 | Jan 29, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | MEDI-524 |
| 2 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 3 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 4 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 5 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| Name | Type | Description |
|---|---|---|
| Medi-524 | BIOLOGICAL | IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals |
| MEDI-524 (Numax-TM) | BIOLOGICAL | Grp.1: 3 mg/kg IV (single dose) |
Inclusion Criteria: * All male or female children must have met all the following criteria: * \[Groups 1, 2, and 3\] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-mont...