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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
136
Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.
Pontificia Universidade Catolica Do Rio Grande
Porto Alegre, Brazil
Hospital Das Clinicas Da Faculdade
Ribeirão Preto, Brazil
Hospital Clinico De La Pointificia Universidad
Santiago, Chile
Hospital Clinico de la Universidad de Chile
Santiago, Chile
Number of Subjects Exhibiting Anti-motavizumab Antibodies
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.
Time frame: Day 0 through 120 days post final dose
Number of Subjects Reporting Adverse Events (AEs)
Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
Time frame: Day 0 through 30 days post final dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Assessments of SAEs were made by clinical investigators according to the protocol.
Time frame: Day 0 through 30 days post final dose
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations
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.
Time frame: Day 0 through 30 days post final dose
Motavizumab Serum Concentrations at Each Data Collection Visit
Mean serum concentration.
Time frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose
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Hospital Dr. Sotero Del Rio
Santiago, Chile
Hospital San Jose
Santiago, Chile