Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
Chronic Lung Disease
About this trial
This is an interventional treatment trial for Chronic Lung Disease
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
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
Active Comparator
Active Comparator
1
2
Liquid Palivizumab
Lyophilized Palivizumab