Serious respiratory syncytial virus (RSV) disease MedDRA version: 7.0 Classification code 10061603
Conditions
Interventions
Product Name: Numax
Product Code: MEDI-524
Pharmaceutical Form: Solution for injection
Current Sponsor code: MEDI-524
Other descriptive name: Humanised IgG1 monoclonal antibody
Concentration unit: mg
Sponsors
MedImmune, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday) with a diagnosis of Chronic Lung Disease of prematurity requiring medical intervention / management (i.e., supplemental oxygen, bronchodilators, or diuretics) within the 6 months before randomization or 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday) 2. 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: 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: Children must have none of the following: 1. Hospitalization at the time of randomization (unless discharge is anticipated within 10 days) 2. Mechanical ventilation or other mechanical support (including CPAP) 3. Life expectancy <6 months 4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) 5. Known renal impairment 6. Known hepatic dysfunction 7. Chronic seizure evolving or unstable or neurologic disorder 8. Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled.) 9. Known immunodeficiency 10. Mother with HIV infection (unless the child has been proven to be not infected) 11. Known allergy to Ig products 12. Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization 13. Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted) 14. Previous receipt of RSV vaccines 15. Participation in other investigational drug product studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of MEDI-524 to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease.;Secondary Objective: 1. To compare the incidence of medically-attended LRIs between treatment groups 2. To compare the incidence of RSV-specific medically-attended LRI in a subset of patients 3. To compare the frequency and incidence of medically-attended OM infections between treatment groups 4. To compare the frequency of prescribed antibiotics for medically-attended LRI and medically-attended OM infections 5. To describe the trough serum concentrations of MEDI-524 6. To describe the immunogenicity of MEDI-524 ;Primary end point(s): The incidence of RSV hospitalization from Study Day 0 through Study Day 150 will be the primary endpoint. Both primary and nosocomial RSV hospitalizations will count as endpoints. In addition, deaths which can be demonstrated to be caused by RSV (by autopsy or clinical history and virologic evidence) will also be considered as primary RSV hospitalization endpoints | — |
Countries
Czech Republic, Denmark, Hungary, Iceland, Italy, Sweden, United Kingdom
Outcome results
None listed