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

Condition(s) targeted: Chronic Lung Disease

Intervention: MEDI-493 (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Genny Losonsky, MD, Study Director, Affiliation: MedImmune LLC

The purpose of this study is to assess the immune reactivity of the liquid formulation of palivizumab to the lyophilized formulation.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome:

The primary endpoint will be assessed by estimating the rates of immune reactivity in the two treatment groups

Two-sided exact confidence intervals for the rates will be constructed

Detailed description: 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.

Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.

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

The University of Alabama School of Medicine, Tuscaloosa, Alabama 35487, United States

Clinical Research Consultants, Hoover, Alabama 35216, United States

Birmingham Pediatric Associates, Birmingham, Alabama 35235, United States

All for Kids Pediatric Clinic, Little Rock, Arkansas 72211, United States

Doctors Medical Group, West Covina, California 91790, United States

Edinger Medical Group, Fountain Valley, California 92708, United States

Convenience Care, West Covina, California 91791, United States

Family Medical Center, Foothill Ranch, California 92610, United States

Norwich Pediatric Group, P.C., Norwich, Connecticut 06360, United States

The Allergy Center at Brookstone, Columbus, Georgia 31904, United States

Physicians to Children and Adolescents, Bardstown, Kentucky 40004, United States

Peak Medical Research LLC, Owensboro, Kentucky 42303, United States

Woburn Pediatric Associates, Woburn, Massachusetts 01801, United States

Pediatric Association of Fall River, Fall River, Massachusetts 02724, United States

Boston University Medical Center, Boston, Massachusetts 02118, United States

Michigan Institute of Medicine, Livonia, Michigan 41852, United States

Meridian Clinical Research, Omaha, Nebraska 68134, United States

St. Joseph's Childrens Hospital, Paterson, New Jersey 07503, United States

Maimonides Pediatric Pulmonology, Brooklyn, New York 11230, United States

Capitol Pediatric And Adolescent Center, Raleigh, North Carolina 27609, United States

North Carlolina Children's & Adult's Clinical Research Foundation/Purcell Clinic, Laurinburg, North Carolina 28352, United States

North Carolina Children's and Adult's Clinical Research Foundation, Sylva, North Carolina 28779, United States

Trinity Medical Group-Health Center Medical Arts, Minot, North Dakota 58701, United States

Medcenter One/Q&R Clinic, Bismarck, North Dakota 58501, United States

Dakota Clinic, Ltd. / Innvois Health, Fargo, North Dakota 58103, United States

Northeast Cincinnati Pediatric Associates, Inc, Mason, Ohio 45040, United States

Dr. Shelly David Senders, M.D., Inc., Cleveland, Ohio 44118, United States

Santiago Reyes, M.D., Oklahoma City, Oklahoma 73112, United States

Temple Univ. Children's Medical Center, Philadelphia, Pennsylvania 19140, United States

CCP - Armstrong Pediatrics, Kittanning, Pennsylvania 16201, United States

Primary Physician's Research, Inc., Pittsburg, Pennsylvania 15241, United States

Greenville Medical Center, Greenville, Pennsylvania 16125, United States

Pediatric Alliance, Southwestern, Pittsburg, Pennsylvania 15236, United States

Pediatric Alliance, Southwestern, Pittsburg, Pennsylvania 15217, United States

Pediatric Alliance of Latrobe, Latrobe, Pennsylvania 15650, United States

South Hills Pediatrics, Pittsburg, Pennsylvania 15227, United States

Tri-State Pediatrics, Beaver Falls, Pennsylvania 15010, United States

Laurel Pediatrics, Uniontown, Pennsylvania 15401, United States

Brown Clinic P.L.L.P./Northridge Clinic, Watertown, South Dakota 57201, United States

Holston Medical Group; Pediatrics at Meadowview Lane, Kingsport, Tennessee 37660, United States

Holston Medical Group; Pediatrics at Stone Plaza, Kingsport, Tennessee 37660, United States

Jackson Clinic, Jackson, Tennessee 38305, United States

Sadler Clinic, Conroe, Texas 77304, United States

Pediatric Associates, Houston, Texas 77087, United States

Quality Assurance Research Center, San Antonio, Texas 78205, United States

Pediatric Allergy/Immunology Associates, PA, Dallas, Texas 75230, United States

MedPro Research, Houston, Texas 77004, United States

Families First Pediatrics, South Jordan, Utah 84095, United States

Utah Valley Pediatrics, Provo, Utah 84604, United States

Wee Care Pediatrics, Layton, Utah 84041, United States

Bear Care Pediatrics, Ogden, Utah 84405, United States

Advanced Pediatrics, Vienna, Virginia 22180, United States

WVU Department of Pediatrics, Charleston, West Virginia 25202, United States

Monroe Clinic, Monroe, Wisconsin 53566, United States

Starting date: October 2005
Ending date: August 2007
Last updated: June 27, 2007