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

Sponsor:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00233064

Purpose

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.

Condition	Intervention	Phase
Chronic Lung Disease	Biological: Lyophilized Palivizumab Biological: Liquid Palivizumab	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Palivizumab

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Number and Percentage of Participants With Immune Reactivity [ Time Frame: Day 240-300 follow up ] [ Designated as safety issue: Yes ]

Enrollment:	417
Study Start Date:	October 2005
Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Liquid Palivizumab	Biological: Liquid Palivizumab Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections. Other Name: Synagis
Active Comparator: 2 Lyophilized Palivizumab	Biological: Lyophilized Palivizumab Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections. Other Name: Synagis

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.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233064

Show 54 Study Locations

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Genny Losonsky, MD

MedImmune LLC

More Information

No publications provided

Responsible Party:	Genevieve Losonsky, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier:	NCT00233064 History of Changes
Other Study ID Numbers:	MI-CP116
Study First Received:	October 3, 2005
Results First Received:	October 2, 2008
Last Updated:	January 7, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lung Diseases
Respiratory Tract Diseases
Palivizumab
Antiviral Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012