MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
This study is designed to describe the safety, tolerability, immunogenicity, and pharmacokinetics of escalating, repeated IM injections (the intended route of administration for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of infants at high risk for serious RSV disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
Hospital General de Niños "Ricardo Gutierrez"
Buenos Aires, Argentina
Hospital Interzonal General de Agudos "Dr. Diego Paroissien
Buenos Aires, Argentina
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, Chile
Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
Time frame: 30 days after patient's final dose of study drug
Pharmacokinetics of MEDI-524
Time frame: · Serum concentrations at each data collection visit will be summarized
Immunogenicity of MEDI-524
Time frame: · Serum ELISA binding activity at each data collection visit will be summarized
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