A study to evaluate the safety, tolerability, and immunogenicity of motavizumab (MEDI-524) after dosing for a second season in children
Study identifier:MI-CP118
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), after Dosing for a Second Season in Children who Previously Received MEDI-524 in Protocol MI-CP104
Medical condition
Motavizumab administration for a second season for RSV prophylaxis
Phase
Phase 1/2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
136
Study type
Interventional
Age
0 Months - 24 Months
Date
Study Start Date: 01 May 2005
Primary Completion Date: 01 Feb 2006
Study Completion Date: 01 Feb 2006
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Apr 2013 by MedImmune
Sponsors
MedImmune
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: motavizumab (MEDI-524) 15 mg/kg A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | Biological/Vaccine: motavizumab (MEDI-524) Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections. Other Name: motavizumab Other Name: Rezield |
| Active Comparator: palivizumab 15 mg/kg A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | Biological/Vaccine: palivizumab 15 mg/kg Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. Other Name: synagis |
Contacts
Investigators
Principal Investigator
M Pamela Griffin
MedImmune LLC
