Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Completed · Phase 3

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The primary objective of this study was to compare the safety and efficacy of motavizumab 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. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Key facts

Study ID

NCT00129766

Run by

MedImmune LLC

People needed

6635

Starts

2004-11-01

Expected to finish

2006-05-01

Last updated by the study team

2013-08-28

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
• OR:
• 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

You may not qualify if…

• Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
• Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
• Life expectancy < 6 months
• Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
• Known renal impairment
• Known hepatic dysfunction
• Chronic seizure or evolving or unstable neurologic disorder
• Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
• 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, VZIG) 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

Where it is running

• Alabama Neonatal Medicine OC — Pike Road, Alabama, United States
• Maricopa Medical Center — Phoenix, Arizona, United States
• Central Arkansas Pediatric Clinic, PA — Benton, Arkansas, United States
• The Children's Clinic Of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States
• Little Rock Children's Clinic, PA — Little Rock, Arkansas, United States
• Miller Children's Hospital — Long Beach, California, United States
• Kaiser Permanente Los Angeles — Los Angeles, California, United States
• Children's Hospital of Oakland — Oakland, California, United States
• Kaiser Permanente Health Care Plan — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California — San Diego, California, United States
• Children's Hospital San Diego — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Children's Hospital — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Pediatric Pulmonology, LLC — Stamford, Connecticut, United States
• A. I. Dupont Hospital For Children — Wilmington, Delaware, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Shands Hospital At The University Of Florida — Gainesville, Florida, United States
• The Nemours Children's Clinic — Jacksonville, Florida, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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