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

Primary Purpose

Chronic Lung Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lyophilized Palivizumab
Liquid Palivizumab
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lung Disease

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Pediatric Associates
  • Clinical Research Consultants
  • The University of Alabama School of Medicine
  • All for Kids Pediatric Clinic
  • Family Medical Center
  • Edinger Medical Group
  • Doctors Medical Group
  • Convenience Care
  • Norwich Pediatric Group, P.C.
  • The Allergy Center at Brookstone
  • Physicians to Children and Adolescents
  • Peak Medical Research LLC
  • Boston University Medical Center
  • Pediatric Association of Fall River
  • Woburn Pediatric Associates
  • Michigan Institute of Medicine
  • Meridian Clinical Research
  • St. Joseph's Childrens Hospital
  • Maimonides Pediatric Pulmonology
  • North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
  • Capitol Pediatric And Adolescent Center
  • North Carolina Children's and Adult's Clinical Research Foundation
  • Medcenter One/Q&R Clinic
  • Dakota Clinic, Ltd. / Innvois Health
  • Trinity Medical Group-Health Center Medical Arts
  • Dr. Shelly David Senders, M.D., Inc.
  • Northeast Cincinnati Pediatric Associates, Inc
  • Santiago Reyes, M.D.
  • Tri-State Pediatrics
  • Greenville Medical Center
  • CCP - Armstrong Pediatrics
  • Pediatric Alliance of Latrobe
  • Temple Univ. Children's Medical Center
  • Pediatric Alliance, Southwestern
  • South Hills Pediatrics
  • Pediatric Alliance, Southwestern
  • Primary Physician's Research, Inc.
  • Laurel Pediatrics
  • Brown Clinic P.L.L.P./Northridge Clinic
  • Jackson Clinic
  • Holston Medical Group; Pediatrics at Meadowview Lane
  • Holston Medical Group; Pediatrics at Stone Plaza
  • Sadler Clinic
  • Pediatric Allergy/Immunology Associates, PA
  • MedPro Research
  • Pediatric Associates
  • Quality Assurance Research Center
  • Wee Care Pediatrics
  • Bear Care Pediatrics
  • Utah Valley Pediatrics
  • Families First Pediatrics
  • Advanced Pediatrics
  • WVU Department of Pediatrics
  • Monroe Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Liquid Palivizumab

Lyophilized Palivizumab

Outcomes

Primary Outcome Measures

Number and Percentage of Participants With Immune Reactivity
Presence of anti-palivizumab antibodies

Secondary Outcome Measures

Full Information

First Posted
October 3, 2005
Last Updated
April 6, 2018
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00233064
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Liquid Palivizumab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lyophilized Palivizumab
Intervention Type
Biological
Intervention Name(s)
Lyophilized Palivizumab
Other Intervention Name(s)
Synagis
Intervention Description
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Intervention Type
Biological
Intervention Name(s)
Liquid Palivizumab
Other Intervention Name(s)
Synagis
Intervention Description
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Primary Outcome Measure Information:
Title
Number and Percentage of Participants With Immune Reactivity
Description
Presence of anti-palivizumab antibodies
Time Frame
Day 240-300 follow up

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genny Losonsky, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Pediatric Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Clinical Research Consultants
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
The University of Alabama School of Medicine
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Facility Name
All for Kids Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Edinger Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Doctors Medical Group
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Convenience Care
City
West Covina
State/Province
California
ZIP/Postal Code
91791
Country
United States
Facility Name
Norwich Pediatric Group, P.C.
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
The Allergy Center at Brookstone
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Physicians to Children and Adolescents
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Peak Medical Research LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Pediatric Association of Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02724
Country
United States
Facility Name
Woburn Pediatric Associates
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
Facility Name
Michigan Institute of Medicine
City
Livonia
State/Province
Michigan
ZIP/Postal Code
41852
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
St. Joseph's Childrens Hospital
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Maimonides Pediatric Pulmonology
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Facility Name
Capitol Pediatric And Adolescent Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
North Carolina Children's and Adult's Clinical Research Foundation
City
Sylva
State/Province
North Carolina
ZIP/Postal Code
28779
Country
United States
Facility Name
Medcenter One/Q&R Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Dakota Clinic, Ltd. / Innvois Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Trinity Medical Group-Health Center Medical Arts
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Dr. Shelly David Senders, M.D., Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Northeast Cincinnati Pediatric Associates, Inc
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Santiago Reyes, M.D.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Tri-State Pediatrics
City
Beaver Falls
State/Province
Pennsylvania
ZIP/Postal Code
15010
Country
United States
Facility Name
Greenville Medical Center
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
CCP - Armstrong Pediatrics
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Facility Name
Pediatric Alliance of Latrobe
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
Temple Univ. Children's Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Pediatric Alliance, Southwestern
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
South Hills Pediatrics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
Facility Name
Pediatric Alliance, Southwestern
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Primary Physician's Research, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Laurel Pediatrics
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Brown Clinic P.L.L.P./Northridge Clinic
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Holston Medical Group; Pediatrics at Meadowview Lane
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Holston Medical Group; Pediatrics at Stone Plaza
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Sadler Clinic
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Pediatric Allergy/Immunology Associates, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
MedPro Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Pediatric Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Quality Assurance Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Bear Care Pediatrics
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Utah Valley Pediatrics
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Families First Pediatrics
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Advanced Pediatrics
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
Facility Name
WVU Department of Pediatrics
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25202
Country
United States
Facility Name
Monroe Clinic
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25156956
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.
Results Reference
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Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

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