Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-534 · 1 trial · 3 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 developed for respiratory viral infections. It was studied for the prevention of respiratory syncytial virus (RSV) and human parainfluenza virus 3 (PIV3) infections in young children. It is not an approved product and remains in clinical development.
MEDI-534 was developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 1 clinical trial evaluating the agent in young children.
MEDI-534 is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.
MEDI-534 was evaluated in a single Phase 1 trial, NCT00493285, titled a safety and tolerability study in children 6 to under 24 months of age. The trial enrolled 49 participants in the United States and has been completed.
The Phase 1 trial NCT00493285 was a randomized, double-blind, active-controlled study. It enrolled 49 children aged 6 to under 24 months in the United States and assessed safety and tolerability in participants with respiratory viral infections, including RSV and parainfluenza virus 3.
MEDI-534 is also referred to as MEDI-534, Cohort 1. These names refer to the same investigational monoclonal antibody developed by AstraZeneca for respiratory viral infections, including respiratory syncytial virus and human parainfluenza virus 3.