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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00129766 | Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children | PHASE3 | COMPLETED | 6,635 | — | — | Nov 1, 2004 | May 1, 2006 | Aug 28, 2013 | 344 | United States, Argentina +22 |
| NCT00316264 | Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season | PHASE2 | COMPLETED | 260 | — | — | Apr 1, 2006 | Feb 1, 2007 | Dec 11, 2012 | 19 | Australia, Chile +1 |
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Number of participants reporting one or more AEs
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of participants reporting one or more SAEs
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
| Arm | Type | Description |
|---|---|---|
| palivizumab | ACTIVE_COMPARATOR | 15 mg/kg administered intramuscularly for 5 monthly doses |
| motavizumab (MEDI-524) | EXPERIMENTAL | 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses |
| Motavizumab followed by Palivizumab | EXPERIMENTAL | 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Palivizumab followed by motavizumab | EXPERIMENTAL | 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab control | EXPERIMENTAL | 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Name | Type | Description |
|---|---|---|
| motavizumab (MEDI-524) | BIOLOGICAL | Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| palivizumab | BIOLOGICAL | Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| Motavizumab, palivizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
| Palivizumab, motavizumab | BIOLOGICAL | Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine. |
| Motavizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
Inclusion Criteria: * 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) wit...