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

April 6, 2018 updated by: MedImmune LLC

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Birmingham Pediatric Associates
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants
      • Tuscaloosa, Alabama, United States, 35487
        • The University of Alabama School of Medicine
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • All for Kids Pediatric Clinic
    • California
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Fountain Valley, California, United States, 92708
        • Edinger Medical Group
      • West Covina, California, United States, 91790
        • Doctors Medical Group
      • West Covina, California, United States, 91791
        • Convenience Care
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric Group, P.C.
    • Georgia
      • Columbus, Georgia, United States, 31904
        • The Allergy Center at Brookstone
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Physicians to Children and Adolescents
      • Owensboro, Kentucky, United States, 42303
        • Peak Medical Research LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
      • Fall River, Massachusetts, United States, 02724
        • Pediatric Association of Fall River
      • Woburn, Massachusetts, United States, 01801
        • Woburn Pediatric Associates
    • Michigan
      • Livonia, Michigan, United States, 41852
        • Michigan Institute of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • New Jersey
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Childrens Hospital
    • New York
      • Brooklyn, New York, United States, 11230
        • Maimonides Pediatric Pulmonology
    • North Carolina
      • Laurinburg, North Carolina, United States, 28352
        • North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
      • Raleigh, North Carolina, United States, 27609
        • Capitol Pediatric And Adolescent Center
      • Sylva, North Carolina, United States, 28779
        • North Carolina Children's and Adult's Clinical Research Foundation
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One/Q&R Clinic
      • Fargo, North Dakota, United States, 58103
        • Dakota Clinic, Ltd. / Innvois Health
      • Minot, North Dakota, United States, 58701
        • Trinity Medical Group-Health Center Medical Arts
    • Ohio
      • Cleveland, Ohio, United States, 44118
        • Dr. Shelly David Senders, M.D., Inc.
      • Mason, Ohio, United States, 45040
        • Northeast Cincinnati Pediatric Associates, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Santiago Reyes, M.D.
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States, 15010
        • Tri-State Pediatrics
      • Greenville, Pennsylvania, United States, 16125
        • Greenville Medical Center
      • Kittanning, Pennsylvania, United States, 16201
        • CCP - Armstrong Pediatrics
      • Latrobe, Pennsylvania, United States, 15650
        • Pediatric Alliance of Latrobe
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Univ. Children's Medical Center
      • Pittsburgh, Pennsylvania, United States, 15227
        • South Hills Pediatrics
      • Pittsburgh, Pennsylvania, United States, 15236
        • Pediatric Alliance, Southwestern
      • Pittsburgh, Pennsylvania, United States, 15217
        • Pediatric Alliance, Southwestern
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physician's Research, Inc.
      • Uniontown, Pennsylvania, United States, 15401
        • Laurel Pediatrics
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinic P.L.L.P./Northridge Clinic
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Jackson Clinic
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group; Pediatrics at Meadowview Lane
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group; Pediatrics at Stone Plaza
    • Texas
      • Conroe, Texas, United States, 77304
        • Sadler Clinic
      • Dallas, Texas, United States, 75230
        • Pediatric Allergy/Immunology Associates, PA
      • Houston, Texas, United States, 77087
        • Pediatric Associates
      • Houston, Texas, United States, 77004
        • MedPro Research
      • San Antonio, Texas, United States, 78205
        • Quality Assurance Research Center
    • Utah
      • Layton, Utah, United States, 84041
        • Wee Care Pediatrics
      • Ogden, Utah, United States, 84405
        • Bear Care Pediatrics
      • Provo, Utah, United States, 84604
        • Utah Valley Pediatrics
      • South Jordan, Utah, United States, 84095
        • Families First Pediatrics
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics
    • West Virginia
      • Charleston, West Virginia, United States, 25202
        • WVU Department of Pediatrics
    • Wisconsin
      • Monroe, Wisconsin, United States, 53566
        • Monroe Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Liquid Palivizumab
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Other Names:
  • Synagis
Active Comparator: 2
Lyophilized Palivizumab
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Other Names:
  • Synagis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Participants With Immune Reactivity
Time Frame: Day 240-300 follow up
Presence of anti-palivizumab antibodies
Day 240-300 follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Genny Losonsky, MD, MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • MI-CP116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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