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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

September 13, 2005
October 23, 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
1 Month to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00192504
MI-CP106
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