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Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

NCT00192504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-10-08

Study results available
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Summary

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Conditions

  • Respiratory Syncytial Virus Prophylaxis

Interventions

BIOLOGICAL

Motavizumab

Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0

BIOLOGICAL

Motavizumab

Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0

BIOLOGICAL

Motavizumab

Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0

OTHER

Placebo

Single dose of placebo administered intravenously (in the vein) on Day 0

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Genevieve A Losonsky, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2005-01-31
Completion
2005-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00192504 on ClinicalTrials.gov