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A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

NCT00421304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-08-27

Study results available
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Summary

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.

Conditions

  • RSV Illness in ≤12 Months of Participants

Interventions

BIOLOGICAL

Motavizumab

A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.

OTHER

Placebo

A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • M. Pamela Griffin, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-10
Primary Completion
2009-09-17
Completion
2009-09-17

Countries

  • United States
  • Australia
  • Chile
  • New Zealand
  • Panama

Study Locations

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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 NCT00421304 on ClinicalTrials.gov