A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States

• Conditions: Serious Lower Respiratory Tract disease caused by RSV; MedDRA version: 14.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000825-33-Outside-EU/EEA
• Lead Sponsor: MedImmune LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 2100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified