Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-559 · 1 trial · 1 indication
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
An SAE is any adverse event that results in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly/birth defect (in the offspring of a subject); an important medical event that may not result in death, threaten life or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, it may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 MEDI-559 | EXPERIMENTAL | MEDI-559 |
| Cohort 1 Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| MEDI-559 | BIOLOGICAL | Cohort 1 (5 to \<24 months): N=80 MEDI-559 at 10\^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10\^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer. |
| Placebo | OTHER | Cohort 1 (5 to \< 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer. |
Inclusion Criteria: * Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 5 to \<24 months (reached their 5th month birthday but not yet reached their 2nd year birthday); Cohort 2: 1 to \< 3 months (\>28 days of age and not yet reached their 3rd m...
MEDI-559 is an investigational monoclonal antibody developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy children, and no approved indication has been announced for it.
MEDI-559 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 study of the antibody in healthy young children.
MEDI-559 is in Phase 1 development. It is an investigational monoclonal antibody and is not an approved product. One Phase 1 trial has been completed, and no active trials are currently listed.
MEDI-559 was evaluated in the Phase 1 trial NCT00767416, titled a randomized, double-blind, placebo-controlled study to evaluate safety of MEDI-559 in healthy 1 to under 24 month old children. The trial enrolled 116 participants across the United States and Puerto Rico and has been completed.
Yes. The Phase 1 trial NCT00767416 was randomized, double-blind, and placebo-controlled. It enrolled 116 healthy children between 1 month and under 24 months of age in the United States and Puerto Rico, and the study has been completed.
MEDI-559 was tested in healthy children aged 1 month to under 24 months to evaluate its safety. The Phase 1 trial NCT00767416 was designed as a safety study in this pediatric population rather than in patients with a specific disease.