Serious Lower Respiratory Tract disease caused by RSV MedDRA version: 14.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: MEDI-524
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MOTAVIZUMAB
CAS Number: 677010-34-3
Other descriptive name: Rezield, MEDI-524
Concentration unit: mg/ml milligra
Sponsors
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday) Male or female Native American General state of good health Written informed consent obtained from the patient's parent(s) or legal guardian Are the trial subjects under 18? yes Number of subjects for this age range: 2100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Gestational age less than or equal to 35 weeks Chronic lung disease of prematurity A bleeding diathesis that would preclude IM injections Hospitalization at the time of randomization (unless discharge is anticipated within 10 days) Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection A documented wheezing episode before enrollment Known renal impairment Known hepatic dysfunction Clinically significant congenital anomaly of the respiratory tract Chronic seizure or evolving or unstable neurologic disorder Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically) Known immunodeficiency Mother with HIV infection (unless the child has been proven to be not infected) Known allergy to Ig products Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG) within 3 months prior to randomization Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted) Previous receipt of RSV vaccines Participation in other investigational drug product studies Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant Inability to complete the study follow-up period through up to 5 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The incidence of RSV hospitalization from Study Day 0 through Study Day 150 of the 1st RSV season will be the primary endpoint;Secondary Objective: Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events and serious adverse events occurring through Study Day 150;Primary end point(s): The incidence of RSV hospitalization from Study Day 0 through Study Day 150 of the 1st RSV season will be the primary endpoint.;Timepoint(s) of evaluation of this end point: Time Frame: Through Day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events and serious adverse events occurring through Study Day 150. ;Timepoint(s) of evaluation of this end point: Time Frame: Through Day 150 | — |
Countries
United States
Contacts
Public ContactMedImmune LLC
MedImmune LLC
Outcome results
None listed