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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524 After Dosing for a Second Season in Children
This study has been completed.
Study NCT00113490   Information provided by MedImmune LLC
First Received: June 8, 2005   Last Updated: December 27, 2007   History of Changes

June 8, 2005
December 27, 2007
October 2006
March 2007   (final data collection date for primary outcome measure)
Immunogenicity of MEDI-524 [ Time Frame: · Serum ELISA binding activity at each data collection visit will be summarized ] [ Designated as safety issue: No ]
- Immunogenicity of MEDI-524
Complete list of historical versions of study NCT00113490 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of MEDI-524 and palivizumab as measured by [ Time Frame: through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of MEDI-524 [ Time Frame: · Serum concentrations at each data collection visit will be summarized ] [ Designated as safety issue: Yes ]
  • - Safety and tolerability of MEDI-524 and palivizumab as measured by:
  • - Adverse events through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug (including the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations)
  • - Serious adverse events through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug
  • - Pharmacokinetics of MEDI-524-Serum concentrations at each data collection visit will be summarized
 
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524 After Dosing for a Second Season in Children
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

The primary objective of this study is to determine the effect on immune reactivity to MEDI-524.

The primary objective of this study is to determine the effect on immune reactivity to MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 administered for a second season, in children who previously received MEDI-524 in protocol MI-CP104. The secondary objectives are to 1) describe the safety and tolerability of MEDI-524 administered for a second season; 2) describe the serum concentration of MEDI-524 administered for a second season.

Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Healthy
Biological: MEDI-524
Active Comparator: Patients will receive 15 mg/kg MEDI-524 or palivizumab administered IM every 30 days for a total of 4-5 injections.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
June 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
  • The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
  • The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
  • Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion Criteria:

  • Be hospitalized
  • Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
  • Evidence of infection with hepatitis A, B, or C virus
  • Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
  • Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
  • Acute illness or progressive clinical disorder
  • Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
  • Previous reaction to IGIV, blood products, or other foreign proteins
  • Have ever received palivizumab
  • Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
  • Currently participating in any investigational study
Both
up to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile
 
NCT00113490
Pam Lupien, M.D., MedImmune Inc.
MI-CP118
MedImmune LLC
 
Study Director: Pam Lupien, M.D. MedImmune LLC
MedImmune LLC
December 2007

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