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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00233064 |
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.
Condition | Intervention | Phase |
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Chronic Lung Disease |
Biological: Lyophilized Palivizumab Biological: Liquid Palivizumab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study |
Official Title: | 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 |
Enrollment: | 417 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Liquid Palivizumab
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Biological: Liquid Palivizumab
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
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2: Active Comparator
Lyophilized Palivizumab
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Biological: Lyophilized Palivizumab
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
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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.
Ages Eligible for Study: | up to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Genny Losonsky, MD | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( Genevieve Lonosky, M.D. ) |
Study ID Numbers: | MI-CP116 |
Study First Received: | October 3, 2005 |
Results First Received: | October 2, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00233064 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Respiratory Tract Diseases Lung Diseases Antiviral Agents Palivizumab |
Anti-Infective Agents Respiratory Tract Diseases Therapeutic Uses Lung Diseases |
Antiviral Agents Palivizumab Pharmacologic Actions |