NCT00628303

A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

Detailed description

The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

Conditions

• Wheezing

Interventions

Type	Name	Description
BIOLOGICAL	Motavizumab	15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
OTHER	Placebo	15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-02-01
• Completion: 2011-12-01
• First posted: 2008-03-05
• Last updated: 2012-08-01