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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00493285 | Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age | PHASE1 | COMPLETED | 49 | — | — | Jul 1, 2007 | Apr 1, 2010 | Jul 19, 2012 | 30 | United States |
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.
Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | MEDI-534 at 10\^4 TCID50 at 0, 2, and 4 months (Nasal spray) |
| 2 | ACTIVE_COMPARATOR | MEDI-534 at 10\^5 TCID50 at 0, 2, and 4 months (Nasal Spray) |
| 3 | ACTIVE_COMPARATOR | MEDI-534 at 10\^6 TCID50 at 0, 2, and 4 months (Nasal Spray) |
| Name | Type | Description |
|---|---|---|
| MEDI-534 | BIOLOGICAL | Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50 |
Inclusion Criteria: * Male or female whose age on the day of randomization is 6 to \<24 months (reached 6th month birthday and not yet reached 2nd year birthday) * Subject is seronegative to both RSV and PIV3 at screening * Subject was the product of normal full term pregnancy (defined as \>36 week...