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

Phase 4

Completed

Conditions: Chronic Lung Disease

Interventions: Biological: Lyophilized Palivizumab
Biological: Liquid Palivizumab

Registration Number: NCT00233064

Lead Sponsor: MedImmune LLC

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 417

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Lyophilized Palivizumab	Lyophilized Palivizumab
1	Liquid Palivizumab	Liquid Palivizumab

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Participants With Immune Reactivity	Day 240-300 follow up	Presence of anti-palivizumab antibodies

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (53): Boston University Medical Center
🇺🇸
Boston, Massachusetts, United States
All for Kids Pediatric Clinic
🇺🇸
Little Rock, Arkansas, United States
Pediatric Association of Fall River
🇺🇸
Fall River, Massachusetts, United States
Meridian Clinical Research
🇺🇸
Omaha, Nebraska, United States
Trinity Medical Group-Health Center Medical Arts
🇺🇸
Minot, North Dakota, United States
Tri-State Pediatrics
🇺🇸
Beaver Falls, Pennsylvania, United States
Holston Medical Group; Pediatrics at Stone Plaza
🇺🇸
Kingsport, Tennessee, United States
Dakota Clinic, Ltd. / Innvois Health
🇺🇸
Fargo, North Dakota, United States
Bear Care Pediatrics
🇺🇸
Ogden, Utah, United States
St. Joseph's Childrens Hospital
🇺🇸
Paterson, New Jersey, United States
Wee Care Pediatrics
🇺🇸
Layton, Utah, United States
Monroe Clinic
🇺🇸
Monroe, Wisconsin, United States
Michigan Institute of Medicine
🇺🇸
Livonia, Michigan, United States
Norwich Pediatric Group, P.C.
🇺🇸
Norwich, Connecticut, United States
WVU Department of Pediatrics
🇺🇸
Charleston, West Virginia, United States
Brown Clinic P.L.L.P./Northridge Clinic
🇺🇸
Watertown, South Dakota, United States
Families First Pediatrics
🇺🇸
South Jordan, Utah, United States
Holston Medical Group; Pediatrics at Meadowview Lane
🇺🇸
Kingsport, Tennessee, United States
Woburn Pediatric Associates
🇺🇸
Woburn, Massachusetts, United States
Jackson Clinic
🇺🇸
Jackson, Tennessee, United States
Utah Valley Pediatrics
🇺🇸
Provo, Utah, United States
Birmingham Pediatric Associates
🇺🇸
Birmingham, Alabama, United States
Clinical Research Consultants
🇺🇸
Hoover, Alabama, United States
Edinger Medical Group
🇺🇸
Fountain Valley, California, United States
Physicians to Children and Adolescents
🇺🇸
Bardstown, Kentucky, United States
The Allergy Center at Brookstone
🇺🇸
Columbus, Georgia, United States
Family Medical Center
🇺🇸
Foothill Ranch, California, United States
Doctors Medical Group
🇺🇸
West Covina, California, United States
Convenience Care
🇺🇸
West Covina, California, United States
Peak Medical Research LLC
🇺🇸
Owensboro, Kentucky, United States
Dr. Shelly David Senders, M.D., Inc.
🇺🇸
Cleveland, Ohio, United States
North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
🇺🇸
Laurinburg, North Carolina, United States
North Carolina Children's and Adult's Clinical Research Foundation
🇺🇸
Sylva, North Carolina, United States
Maimonides Pediatric Pulmonology
🇺🇸
Brooklyn, New York, United States
Capitol Pediatric And Adolescent Center
🇺🇸
Raleigh, North Carolina, United States
CCP - Armstrong Pediatrics
🇺🇸
Kittanning, Pennsylvania, United States
Santiago Reyes, M.D.
🇺🇸
Oklahoma City, Oklahoma, United States
Northeast Cincinnati Pediatric Associates, Inc
🇺🇸
Mason, Ohio, United States
Greenville Medical Center
🇺🇸
Greenville, Pennsylvania, United States
Temple Univ. Children's Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Pediatric Alliance, Southwestern
🇺🇸
Pittsburgh, Pennsylvania, United States
South Hills Pediatrics
🇺🇸
Pittsburgh, Pennsylvania, United States
Pediatric Alliance of Latrobe
🇺🇸
Latrobe, Pennsylvania, United States
Primary Physician's Research, Inc.
🇺🇸
Pittsburgh, Pennsylvania, United States
Laurel Pediatrics
🇺🇸
Uniontown, Pennsylvania, United States
MedPro Research
🇺🇸
Houston, Texas, United States
Pediatric Associates
🇺🇸
Houston, Texas, United States
Pediatric Allergy/Immunology Associates, PA
🇺🇸
Dallas, Texas, United States
Quality Assurance Research Center
🇺🇸
San Antonio, Texas, United States
Sadler Clinic
🇺🇸
Conroe, Texas, United States
Advanced Pediatrics
🇺🇸
Vienna, Virginia, United States
Medcenter One/Q&R Clinic
🇺🇸
Bismarck, North Dakota, United States
The University of Alabama School of Medicine
🇺🇸
Tuscaloosa, Alabama, United States