A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00113490
First received: June 8, 2005
Last updated: April 3, 2013
Last verified: April 2013

June 8, 2005
April 3, 2013
May 2005
February 2006   (final data collection date for primary outcome measure)
Number of Subjects Exhibiting Anti-motavizumab Antibodies [ Time Frame: Day 0 through 120 days post final dose ] [ Designated as safety issue: Yes ]
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
Not Provided
Complete list of historical versions of study NCT00113490 on ClinicalTrials.gov Archive Site
  • Number of Subjects Reporting Adverse Events (AEs) [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
    Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
    Assessments of SAEs were made by clinical investigators according to the protocol.
  • Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations [ Time Frame: Day 0 through 30 days post final dose ] [ Designated as safety issue: Yes ]
    Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.
  • Motavizumab Serum Concentrations at Each Data Collection Visit [ Time Frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose ] [ Designated as safety issue: No ]
    Mean serum concentration.
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (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 was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Motavizumab Administration for a Second Season for RSV Prophylaxis
  • Biological: motavizumab (MEDI-524)
    Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
    Other Names:
    • motavizumab
    • Rezield
  • Biological: palivizumab 15 mg/kg
    Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.
    Other Name: synagis
  • Experimental: motavizumab (MEDI-524) 15 mg/kg
    A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
    Intervention: Biological: motavizumab (MEDI-524)
  • Active Comparator: palivizumab 15 mg/kg
    A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
    Intervention: Biological: palivizumab 15 mg/kg
Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
February 2006
February 2006   (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:

  • Currently 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
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile
 
NCT00113490
MI-CP118
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: M Pamela Griffin, M.D. MedImmune LLC
MedImmune LLC
April 2013

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