NCT00435227

A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

Detailed description

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (\<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.

Conditions

• Participants Less Than 12 Months of Age With RSV Illness

Interventions

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

Timeline

• Start date: 2007-03-20
• Primary completion: 2008-05-31
• Completion: 2008-05-31
• First posted: 2007-02-14
• Last updated: 2021-08-17
• Results posted: 2021-08-17

Locations

31 sites across 1 country: United States