NCT00421304

A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

Detailed description

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Conditions

• RSV Illness in ≤12 Months of Participants

Interventions

Type	Name	Description
BIOLOGICAL	Motavizumab	A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.
OTHER	Placebo	A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Timeline

• Start date: 2007-01-10
• Primary completion: 2009-09-17
• Completion: 2009-09-17
• First posted: 2007-01-11
• Last updated: 2021-08-27
• Results posted: 2021-08-27

Locations

35 sites across 5 countries: United States, Australia, Chile, New Zealand, Panama