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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01006629 | Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children | PHASE2 | COMPLETED | 100 | — | — | Nov 1, 2009 | Jul 1, 2010 | Jul 19, 2011 | 19 | Russia |
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.
Number of subjects experiencing an RSV hospitalization
| Arm | Type | Description |
|---|---|---|
| palivizumab | EXPERIMENTAL | palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections |
| Name | Type | Description |
|---|---|---|
| palivizumab | BIOLOGICAL | palivizumab 15 mg/kg intramuscularly |
Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled into the study: 1. Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: * Infants born at less than or equal to 35 weeks gestational age AND are less than or equal t...