A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

• Number of Subjects Exhibiting Anti-motavizumab Antibodies [ Time Frame: Day 0 through 120 days post final dose ] [ Designated as safety issue: Yes ]
  Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
  
  

• Number of Subjects Reporting Adverse Events (AEs) [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
  Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
  
  
• Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
  Assessments of SAEs were made by clinical investigators according to the protocol.
  
  
• Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
  Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.
  
  
• Motavizumab Serum Concentrations at Each Data Collection Visit [ Time Frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose ] [ Designated as safety issue: No ]
  Mean serum concentration.
  
  

This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.