Clinical trial NCT00233064: Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Lung Disease
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 417
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number and Percentage of Participants With Immune Reactivity
timeFrame: Day 240-300 follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Tuscaloosa
country: United States
facility: The University of Alabama School of Medicine
state: Alabama
city: Little Rock
country: United States
facility: All for Kids Pediatric Clinic
state: Arkansas
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Fountain Valley
country: United States
facility: Edinger Medical Group
state: California
city: West Covina
country: United States
facility: Doctors Medical Group
state: California
city: West Covina
country: United States
facility: Convenience Care
state: California
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Columbus
country: United States
facility: The Allergy Center at Brookstone
state: Georgia
city: Bardstown
country: United States
facility: Physicians to Children and Adolescents
state: Kentucky
city: Owensboro
country: United States
facility: Peak Medical Research LLC
state: Kentucky
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Pediatric Association of Fall River
state: Massachusetts
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Livonia
country: United States
facility: Michigan Institute of Medicine
state: Michigan
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Paterson
country: United States
facility: St. Joseph's Childrens Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Pediatric Pulmonology
state: New York
city: Laurinburg
country: United States
facility: North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Capitol Pediatric And Adolescent Center
state: North Carolina
city: Sylva
country: United States
facility: North Carolina Children's and Adult's Clinical Research Foundation
state: North Carolina
city: Bismarck
country: United States
facility: Medcenter One/Q&R Clinic
state: North Dakota
city: Fargo
country: United States
facility: Dakota Clinic, Ltd. / Innvois Health
state: North Dakota
city: Minot
country: United States
facility: Trinity Medical Group-Health Center Medical Arts
state: North Dakota
city: Cleveland
country: United States
facility: Dr. Shelly David Senders, M.D., Inc.
state: Ohio
city: Mason
country: United States
facility: Northeast Cincinnati Pediatric Associates, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Santiago Reyes, M.D.
state: Oklahoma
city: Beaver Falls
country: United States
facility: Tri-State Pediatrics
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Medical Center
state: Pennsylvania
city: Kittanning
country: United States
facility: CCP - Armstrong Pediatrics
state: Pennsylvania
city: Latrobe
country: United States
facility: Pediatric Alliance of Latrobe
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Univ. Children's Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance, Southwestern
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance, Southwestern
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physician's Research, Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Laurel Pediatrics
state: Pennsylvania
city: Watertown
country: United States
facility: Brown Clinic P.L.L.P./Northridge Clinic
state: South Dakota
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group; Pediatrics at Meadowview Lane
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group; Pediatrics at Stone Plaza
state: Tennessee
city: Conroe
country: United States
facility: Sadler Clinic
state: Texas
city: Dallas
country: United States
facility: Pediatric Allergy/Immunology Associates, PA
state: Texas
city: Houston
country: United States
facility: MedPro Research
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Ogden
country: United States
facility: Bear Care Pediatrics
state: Utah
city: Provo
country: United States
facility: Utah Valley Pediatrics
state: Utah
city: South Jordan
country: United States
facility: Families First Pediatrics
state: Utah
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Charleston
country: United States
facility: WVU Department of Pediatrics
state: West Virginia
city: Monroe
country: United States
facility: Monroe Clinic
state: Wisconsin
Study officials:
affiliation: MedImmune LLC
name: Genny Losonsky, MD
role: STUDY_DIRECTOR
References:
citation: 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.