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

Chronic Lung Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233064
• Other study ID #: MI-CP116
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: January 2010
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Makari D, Jensen KM, Harris B, Jafri HS. Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity. Infect Dis Ther. 2014 Dec;3(2):339-47. doi: 10.1007/s40121-014-0033-y. Epub 2014 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Percentage of Participants With Immune Reactivity	Presence of anti-palivizumab antibodies	Day 240-300 follow up