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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00421304 |
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
Condition | Intervention | Phase |
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Respiratory Syncytial Virus (RSV) |
Biological: Motavizumab Other: Biological/Vaccine: Motavizumab Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness |
Estimated Enrollment: | 150 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MEDI-524 or Motavizumab
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Biological: Motavizumab
Will receive a single dose of IV of Motavizumab (100mg/kg)
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2: Experimental
MEDI-524 or Motavizumab
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Other: Biological/Vaccine: Motavizumab
A single IV dose of placebo (30 mg/kg).
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3: Placebo Comparator
Placebo
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Other: Placebo
A single IV dose of placebo (30 or 100 mg/kg).
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The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.
Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Children must meet all of the following criteria:
Exclusion Criteria:
Children must have none of the following:
Contact: Terramika Bellamy | 301-398-4994 | bellamyt@medimmune.com |
Contact: Joe Coffie | 301-398-4723 | coffiej@medimmune.com |
Study Director: | M. Pamela Griffin, M.D. | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( M. Pamela Griffin ) |
Study ID Numbers: | MI-CP141 |
Study First Received: | January 9, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00421304 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Virus Diseases Antibodies Immunoglobulins |