Status:
COMPLETED
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
Lead Sponsor:
MedImmune LLC
Conditions:
Chronic Lung Disease
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE4
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 formula...
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT00233064
Start Date
October 1 2005
End Date
November 1 2007
Last Update
June 27 2018
Active Locations (54)
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1
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35235
2
Clinical Research Consultants
Hoover, Alabama, United States, 35216
3
The University of Alabama School of Medicine
Tuscaloosa, Alabama, United States, 35487
4
All for Kids Pediatric Clinic
Little Rock, Arkansas, United States, 72211