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

NCT ID: NCT00233064

Last Updated: 2018-06-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Liquid Palivizumab

Group Type ACTIVE_COMPARATOR

Liquid Palivizumab

Intervention Type BIOLOGICAL

Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.

2

Lyophilized Palivizumab

Group Type ACTIVE_COMPARATOR

Lyophilized Palivizumab

Intervention Type BIOLOGICAL

Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Interventions

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Lyophilized Palivizumab

Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Intervention Type BIOLOGICAL

Liquid Palivizumab

Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Intervention Type BIOLOGICAL

Other Intervention Names

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Synagis Synagis

Eligibility Criteria

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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
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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MedImmune Inc.

Principal Investigators

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Genny Losonsky, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Birmingham Pediatric Associates

Birmingham, Alabama, United States

Site Status

Clinical Research Consultants

Hoover, Alabama, United States

Site Status

The University of Alabama School of Medicine

Tuscaloosa, Alabama, United States

Site Status

All for Kids Pediatric Clinic

Little Rock, Arkansas, United States

Site Status

Family Medical Center

Foothill Ranch, California, United States

Site Status

Edinger Medical Group

Fountain Valley, California, United States

Site Status

Doctors Medical Group

West Covina, California, United States

Site Status

Convenience Care

West Covina, California, United States

Site Status

Norwich Pediatric Group, P.C.

Norwich, Connecticut, United States

Site Status

The Allergy Center at Brookstone

Columbus, Georgia, United States

Site Status

Physicians to Children and Adolescents

Bardstown, Kentucky, United States

Site Status

Peak Medical Research LLC

Owensboro, Kentucky, United States

Site Status

Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Pediatric Association of Fall River

Fall River, Massachusetts, United States

Site Status

Woburn Pediatric Associates

Woburn, Massachusetts, United States

Site Status

Michigan Institute of Medicine

Livonia, Michigan, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

St. Joseph's Childrens Hospital

Paterson, New Jersey, United States

Site Status

Maimonides Pediatric Pulmonology

Brooklyn, New York, United States

Site Status

North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic

Laurinburg, North Carolina, United States

Site Status

Capitol Pediatric And Adolescent Center

Raleigh, North Carolina, United States

Site Status

North Carolina Children's and Adult's Clinical Research Foundation

Sylva, North Carolina, United States

Site Status

Medcenter One/Q&R Clinic

Bismarck, North Dakota, United States

Site Status

Dakota Clinic, Ltd. / Innvois Health

Fargo, North Dakota, United States

Site Status

Trinity Medical Group-Health Center Medical Arts

Minot, North Dakota, United States

Site Status

Dr. Shelly David Senders, M.D., Inc.

Cleveland, Ohio, United States

Site Status

Northeast Cincinnati Pediatric Associates, Inc

Mason, Ohio, United States

Site Status

Santiago Reyes, M.D.

Oklahoma City, Oklahoma, United States

Site Status

Tri-State Pediatrics

Beaver Falls, Pennsylvania, United States

Site Status

Greenville Medical Center

Greenville, Pennsylvania, United States

Site Status

CCP - Armstrong Pediatrics

Kittanning, Pennsylvania, United States

Site Status

Pediatric Alliance of Latrobe

Latrobe, Pennsylvania, United States

Site Status

Temple Univ. Children's Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Pediatric Alliance, Southwestern

Pittsburgh, Pennsylvania, United States

Site Status

South Hills Pediatrics

Pittsburgh, Pennsylvania, United States

Site Status

Pediatric Alliance, Southwestern

Pittsburgh, Pennsylvania, United States

Site Status

Primary Physician's Research, Inc.

Pittsburgh, Pennsylvania, United States

Site Status

Laurel Pediatrics

Uniontown, Pennsylvania, United States

Site Status

Brown Clinic P.L.L.P./Northridge Clinic

Watertown, South Dakota, United States

Site Status

Jackson Clinic

Jackson, Tennessee, United States

Site Status

Holston Medical Group; Pediatrics at Meadowview Lane

Kingsport, Tennessee, United States

Site Status

Holston Medical Group; Pediatrics at Stone Plaza

Kingsport, Tennessee, United States

Site Status

Sadler Clinic

Conroe, Texas, United States

Site Status

Pediatric Allergy/Immunology Associates, PA

Dallas, Texas, United States

Site Status

MedPro Research

Houston, Texas, United States

Site Status

Pediatric Associates

Houston, Texas, United States

Site Status

Quality Assurance Research Center

San Antonio, Texas, United States

Site Status

Wee Care Pediatrics

Layton, Utah, United States

Site Status

Bear Care Pediatrics

Ogden, Utah, United States

Site Status

Utah Valley Pediatrics

Provo, Utah, United States

Site Status

Families First Pediatrics

South Jordan, Utah, United States

Site Status

Advanced Pediatrics

Vienna, Virginia, United States

Site Status

WVU Department of Pediatrics

Charleston, West Virginia, United States

Site Status

Monroe Clinic

Monroe, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25156956 (View on PubMed)

Other Identifiers

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MI-CP116

Identifier Type: -

Identifier Source: org_study_id

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