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

• 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.

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

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.

• Biological: motavizumab (MEDI-524)
  Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
  Other Names:

  • motavizumab
  • Rezield
• Biological: palivizumab 15 mg/kg
  Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.
  Other Name: synagis

• Experimental: motavizumab (MEDI-524) 15 mg/kg
  A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
  Intervention: Biological: motavizumab (MEDI-524)
• Active Comparator: palivizumab 15 mg/kg
  A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
  Intervention: Biological: palivizumab 15 mg/kg

Inclusion Criteria:

• Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
• The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
• The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
• Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion Criteria:

• Currently hospitalized
• Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
• Evidence of infection with hepatitis A, B, or C virus
• Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
• Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
• Acute illness or progressive clinical disorder
• Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
• Previous reaction to IGIV, blood products, or other foreign proteins
• Have ever received palivizumab
• Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
• Currently participating in any investigational study