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

Completed · Phase 4

Conditions studied: Chronic Lung Disease

In brief

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.

Key facts

Study ID

NCT00233064

Run by

MedImmune LLC

People needed

417

Starts

2005-10-01

Expected to finish

2007-11-01

Last updated by the study team

2018-06-27

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
• Written informed consent obtained from the patient's parent(s) or legal guardian(s)
• The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug

You may not qualify if…

• Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
• Be receiving mechanical ventilation at the time of study entry (including CPAP)
• Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
• Mother with HIV infection (unless the child has been proven to be not infected)
• Life expectancy <6 months
• Known allergy to Ig products
• Acute respiratory or other acute infection or illness
• Previous reaction to IGIV, blood products, or other foreign proteins
• Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
• Any previous receipt of MEDI-524
• Participation in other investigational drug product studies

Where it is running

• Clinical Research Consultants — Hoover, Alabama, United States
• The University of Alabama School of Medicine — Tuscaloosa, Alabama, United States
• All for Kids Pediatric Clinic — Little Rock, Arkansas, United States
• Family Medical Center — Foothill Ranch, California, United States
• Edinger Medical Group — Fountain Valley, California, United States
• Doctors Medical Group — West Covina, California, United States
• Convenience Care — West Covina, California, United States
• Norwich Pediatric Group, P.C. — Norwich, Connecticut, United States
• The Allergy Center at Brookstone — Columbus, Georgia, United States
• Physicians to Children and Adolescents — Bardstown, Kentucky, United States
• Peak Medical Research LLC — Owensboro, Kentucky, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Pediatric Association of Fall River — Fall River, Massachusetts, United States
• Woburn Pediatric Associates — Woburn, Massachusetts, United States
• Michigan Institute of Medicine — Livonia, Michigan, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• St. Joseph's Childrens Hospital — Paterson, New Jersey, United States
• Maimonides Pediatric Pulmonology — Brooklyn, New York, United States
• North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic — Laurinburg, North Carolina, United States
• Capitol Pediatric And Adolescent Center — Raleigh, North Carolina, United States
• North Carolina Children's and Adult's Clinical Research Foundation — Sylva, North Carolina, United States
• Medcenter One/Q&R Clinic — Bismarck, North Dakota, United States
• Dakota Clinic, Ltd. / Innvois Health — Fargo, North Dakota, United States
• Trinity Medical Group-Health Center Medical Arts — Minot, North Dakota, United States
• Birmingham Pediatric Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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