NCT00233064

Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.

Detailed description

The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.

Conditions

• Chronic Lung Disease

Interventions

Type	Name	Description
BIOLOGICAL	Lyophilized Palivizumab	Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
BIOLOGICAL	Liquid Palivizumab	Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-10-01
• Completion: 2007-11-01
• First posted: 2005-10-05
• Last updated: 2018-06-27
• Results posted: 2008-10-28

Locations

54 sites across 1 country: United States