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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:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192504
First received: September 13, 2005
Last updated: October 23, 2006
Last verified: October 2006
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192504

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

No publications provided

ClinicalTrials.gov Identifier: NCT00192504     History of Changes
Other Study ID Numbers: MI-CP106
Study First Received: September 13, 2005
Last Updated: October 23, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013