Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-534 · 2 trials · 4 indications
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...
MEDI-534 is an investigational monoclonal antibody being studied for the prevention of respiratory viral infections, specifically respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3), in healthy children. It is currently in Phase 1 clinical development and is not yet approved for any use.
MEDI-534 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational monoclonal antibody in pediatric populations.
MEDI-534 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total enrollment of 120 participants in one study and 49 in another.
MEDI-534 has been studied in two completed Phase 1 trials. NCT00345670 evaluated its safety in healthy children against RSV and PIV3, enrolling 120 participants. NCT00493285 assessed safety and tolerability in children aged 6 to <24 months, enrolling 49 participants. Both trials were conducted in the United States.
MEDI-534 is a monoclonal antibody designed to target respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3). By binding to these viruses, it is intended to neutralize them and prevent infection in healthy children. Its exact mechanism of action is under investigation in clinical trials.