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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192504
First Posted: September 19, 2005
Last Update Posted: October 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MedImmune LLC
  Purpose
MEDI-524 administered as a single IV dose at 3, 15, and 30 mg/kg to children hospitalized with RSV infection was safe and well tolerated.

Condition Intervention Phase
Respiratory Syncytial Virus Infections Biological: MEDI-524 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To describe the safety and tolerability of a single intravenous dose of MEDI-524
  • To describe the serum concentrations of IV administered MEDI-524

Secondary Outcome Measures:
  • To describe the immunogenicity of MEDI-524 following a single IV dose

Estimated Enrollment: 31
Study Start Date: March 2004
Estimated Study Completion Date: January 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All male or female children must have met all of the following criteria:
  • Previously healthy
  • Age £24 months at the time of randomization
  • Gestational age ³36 weeks gestation
  • Randomization within 24 hours after hospitalization
  • Hospitalized for lower respiratory tract illness (i.e. RSV bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Exclusion Criteria:

  • Patients who met any of the following criteria were not eligible for entry into the study:
  • Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
  • Required intubation for ventilatory support
  • Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
  • Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
  • Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
  • Mechanical ventilation at any time prior to the onset of the current RSV infection
  • Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
  • Previous reaction to IVIG, blood products, or other foreign proteins
  • Prior use of IVIG, RSV-IGIV (RespiGamÒ), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
  • Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
  • Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192504


Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Genevieve Losonsky, MD MedImmune LLC
  More Information

ClinicalTrials.gov Identifier: NCT00192504     History of Changes
Other Study ID Numbers: MI-CP106
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: October 25, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs