We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00192504
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 25, 2006
Sponsor:
Information provided by:

September 13, 2005
September 19, 2005
October 25, 2006
March 2004
Not Provided
  • To describe the safety and tolerability of a single intravenous dose of MEDI-524
  • To describe the serum concentrations of IV administered MEDI-524
  • - To describe the safety and tolerability of a single intravenous dose of MEDI-524 administered at 3 mg/kg, 15 mg/kg, and 30 mg/kg in otherwise healthy infants hospitalized for RSV infection
  • - To describe the serum concentrations of IV administered MEDI-524 in these children with RSV infection
Complete list of historical versions of study NCT00192504 on ClinicalTrials.gov Archive Site
To describe the immunogenicity of MEDI-524 following a single IV dose
- To describe the immunogenicity of MEDI-524 following a single IV dose
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Respiratory Syncytial Virus Infections
Biological: MEDI-524
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2005
Not Provided

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
Sexes Eligible for Study: All
1 Month to 24 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00192504
MI-CP106
Not Provided
Not Provided
Not Provided
Not Provided
MedImmune LLC
Not Provided
Study Director: Genevieve Losonsky, MD MedImmune LLC
MedImmune LLC
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP