Study to Assess the Immune Reactivity of the Liquid & Lyophilized

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00233064
Study type	Interventional
Source	MedImmune LLC
Contact
Status	Completed
Phase	Phase 4
Start date	October 2005
Completion date	November 2007

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms