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

Sponsor:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00233064

Purpose

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
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

Resource links provided by NLM:

Drug Information available for: Palivizumab

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Number and Percentage of Participants With Immune Reactivity [ Time Frame: Day 240-300 follow up ] [ Designated as safety issue: Yes ]

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
1: Active Comparator Liquid Palivizumab	Biological: Liquid Palivizumab Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
2: Active Comparator Lyophilized Palivizumab	Biological: Lyophilized Palivizumab Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.

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.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233064

Hide Study Locations

Locations

United States, Alabama
The University of Alabama School of Medicine
Tuscaloosa, Alabama, United States, 35487
Clinical Research Consultants
Hoover, Alabama, United States, 35216
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35235
United States, Arkansas
All for Kids Pediatric Clinic
Little Rock, Arkansas, United States, 72211
United States, California
Doctors Medical Group
West Covina, California, United States, 91790
Edinger Medical Group
Fountain Valley, California, United States, 92708
Convenience Care
West Covina, California, United States, 91791
Family Medical Center
Foothill Ranch, California, United States, 92610
United States, Connecticut
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States, 06360
United States, Georgia
The Allergy Center at Brookstone
Columbus, Georgia, United States, 31904
United States, Kentucky
Physicians to Children and Adolescents
Bardstown, Kentucky, United States, 40004
Peak Medical Research LLC
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Woburn Pediatric Associates
Woburn, Massachusetts, United States, 01801
Pediatric Association of Fall River
Fall River, Massachusetts, United States, 02724
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Institute of Medicine
Livonia, Michigan, United States, 41852
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New Jersey
St. Joseph's Childrens Hospital
Paterson, New Jersey, United States, 07503
United States, New York
Maimonides Pediatric Pulmonology
Brooklyn, New York, United States, 11230
United States, North Carolina
Capitol Pediatric And Adolescent Center
Raleigh, North Carolina, United States, 27609
North Carlolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
Laurinburg, North Carolina, United States, 28352
North Carolina Children's and Adult's Clinical Research Foundation
Sylva, North Carolina, United States, 28779
United States, North Dakota
Trinity Medical Group-Health Center Medical Arts
Minot, North Dakota, United States, 58701
Medcenter One/Q&R Clinic
Bismarck, North Dakota, United States, 58501
Dakota Clinic, Ltd. / Innvois Health
Fargo, North Dakota, United States, 58103
United States, Ohio
Northeast Cincinnati Pediatric Associates, Inc
Mason, Ohio, United States, 45040
Dr. Shelly David Senders, M.D., Inc.
Cleveland, Ohio, United States, 44118
United States, Oklahoma
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Temple Univ. Children's Medical Center
Philadelphia, Pennsylvania, United States, 19140
CCP - Armstrong Pediatrics
Kittanning, Pennsylvania, United States, 16201
Primary Physician's Research, Inc.
Pittsburgh, Pennsylvania, United States, 15241
Pediatric Alliance, Southwestern
Pittsburg, Pennsylvania, United States, 15217
Pediatric Alliance, Southwestern
Pittsburg, Pennsylvania, United States, 15236
Greenville Medical Center
Greenville, Pennsylvania, United States, 16125
Pediatric Alliance of Latrobe
Latrobe, Pennsylvania, United States, 15650
South Hills Pediatrics
Pittsburg, Pennsylvania, United States, 15227
Tri-State Pediatrics
Beaver Falls, Pennsylvania, United States, 15010
Laurel Pediatrics
Uniontown, Pennsylvania, United States, 15401
United States, South Dakota
Brown Clinic P.L.L.P./Northridge Clinic
Watertown, South Dakota, United States, 57201
United States, Tennessee
Holston Medical Group; Pediatrics at Meadowview Lane
Kingsport, Tennessee, United States, 37660
Holston Medical Group; Pediatrics at Stone Plaza
Kingsport, Tennessee, United States, 37660
Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Texas
Sadler Clinic
Conroe, Texas, United States, 77304
Pediatric Associates
Houston, Texas, United States, 77087
Quality Assurance Research Center
San Antonio, Texas, United States, 78205
Pediatric Allergy/Immunology Associates, PA
Dallas, Texas, United States, 75230
MedPro Research
Houston, Texas, United States, 77004
United States, Utah
Families First Pediatrics
South Jordan, Utah, United States, 84095
Utah Valley Pediatrics
Provo, Utah, United States, 84604
Wee Care Pediatrics
Layton, Utah, United States, 84041
Bear Care Pediatrics
Ogden, Utah, United States, 84405
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
United States, West Virginia
WVU Department of Pediatrics
Charleston, West Virginia, United States, 25202
United States, Wisconsin
Monroe Clinic
Monroe, Wisconsin, United States, 53566

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Genny Losonsky, MD

MedImmune LLC

More Information

No publications provided

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

Additional relevant MeSH terms:

Antibodies, Monoclonal
Anti-Infective Agents
Immunologic Factors
Respiratory Tract Diseases
Therapeutic Uses

Lung Diseases
Physiological Effects of Drugs
Antiviral Agents
Palivizumab
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009