Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
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
1 other identifier
interventional
417
1 country
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
Typical duration for phase_4
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
October 28, 2008
CompletedJune 27, 2018
January 1, 2010
2 years
October 3, 2005
October 2, 2008
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number and Percentage of Participants With Immune Reactivity
Presence of anti-palivizumab antibodies
Day 240-300 follow up
Study Arms (2)
1
ACTIVE COMPARATORLiquid Palivizumab
2
ACTIVE COMPARATORLyophilized Palivizumab
Interventions
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (54)
Birmingham Pediatric Associates
Birmingham, Alabama, 35235, United States
Clinical Research Consultants
Hoover, Alabama, 35216, United States
The University of Alabama School of Medicine
Tuscaloosa, Alabama, 35487, United States
All for Kids Pediatric Clinic
Little Rock, Arkansas, 72211, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
Edinger Medical Group
Fountain Valley, California, 92708, United States
Doctors Medical Group
West Covina, California, 91790, United States
Convenience Care
West Covina, California, 91791, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360, United States
The Allergy Center at Brookstone
Columbus, Georgia, 31904, United States
Physicians to Children and Adolescents
Bardstown, Kentucky, 40004, United States
Peak Medical Research LLC
Owensboro, Kentucky, 42303, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Pediatric Association of Fall River
Fall River, Massachusetts, 02724, United States
Woburn Pediatric Associates
Woburn, Massachusetts, 01801, United States
Michigan Institute of Medicine
Livonia, Michigan, 41852, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
St. Joseph's Childrens Hospital
Paterson, New Jersey, 07503, United States
Maimonides Pediatric Pulmonology
Brooklyn, New York, 11230, United States
North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
Laurinburg, North Carolina, 28352, United States
Capitol Pediatric And Adolescent Center
Raleigh, North Carolina, 27609, United States
North Carolina Children's and Adult's Clinical Research Foundation
Sylva, North Carolina, 28779, United States
Medcenter One/Q&R Clinic
Bismarck, North Dakota, 58501, United States
Dakota Clinic, Ltd. / Innvois Health
Fargo, North Dakota, 58103, United States
Trinity Medical Group-Health Center Medical Arts
Minot, North Dakota, 58701, United States
Dr. Shelly David Senders, M.D., Inc.
Cleveland, Ohio, 44118, United States
Northeast Cincinnati Pediatric Associates, Inc
Mason, Ohio, 45040, United States
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, 73112, United States
Tri-State Pediatrics
Beaver Falls, Pennsylvania, 15010, United States
Greenville Medical Center
Greenville, Pennsylvania, 16125, United States
CCP - Armstrong Pediatrics
Kittanning, Pennsylvania, 16201, United States
Pediatric Alliance of Latrobe
Latrobe, Pennsylvania, 15650, United States
Temple Univ. Children's Medical Center
Philadelphia, Pennsylvania, 19140, United States
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, 15217, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227, United States
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, 15236, United States
Primary Physician's Research, Inc.
Pittsburgh, Pennsylvania, 15241, United States
Laurel Pediatrics
Uniontown, Pennsylvania, 15401, United States
Brown Clinic P.L.L.P./Northridge Clinic
Watertown, South Dakota, 57201, United States
Jackson Clinic
Jackson, Tennessee, 38305, United States
Holston Medical Group; Pediatrics at Meadowview Lane
Kingsport, Tennessee, 37660, United States
Holston Medical Group; Pediatrics at Stone Plaza
Kingsport, Tennessee, 37660, United States
Sadler Clinic
Conroe, Texas, 77304, United States
Pediatric Allergy/Immunology Associates, PA
Dallas, Texas, 75230, United States
MedPro Research
Houston, Texas, 77004, United States
Pediatric Associates
Houston, Texas, 77087, United States
Quality Assurance Research Center
San Antonio, Texas, 78205, United States
Wee Care Pediatrics
Layton, Utah, 84041, United States
Bear Care Pediatrics
Ogden, Utah, 84405, United States
Utah Valley Pediatrics
Provo, Utah, 84604, United States
Families First Pediatrics
South Jordan, Utah, 84095, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
WVU Department of Pediatrics
Charleston, West Virginia, 25202, United States
Monroe Clinic
Monroe, Wisconsin, 53566, United States
Related 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.
PMID: 25156956BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only serious adverse events were collected as part of the safety evaluation. One death (asphyxia) occurred in the Lyophilized Palivizumab group; this event was judged not related to study drug.
Results Point of Contact
- Title
- Hasan S. Jafri, MD
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Genny Losonsky, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
October 1, 2005
Primary Completion
October 1, 2007
Study Completion
November 1, 2007
Last Updated
June 27, 2018
Results First Posted
October 28, 2008
Record last verified: 2010-01