NCT00192478

Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

A Phase 1/2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children at Risk for Serious RSV Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Medi-524	IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-05-01
• Completion: 2006-08-01
• First posted: 2005-09-19
• Last updated: 2008-07-28

Locations

3 sites across 2 countries: Argentina, Chile