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
  Purpose

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.


Condition Intervention Phase
Motavizumab Administration for a Second Season for RSV Prophylaxis
Biological: motavizumab (MEDI-524)
Biological: palivizumab 15 mg/kg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 136
Study Start Date: May 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113490

Locations
Brazil
Pontificia Universidade Catolica Do Rio Grande
Porto Alegre, Brazil, 90610-000
Hospital Das Clinicas Da Faculdade
Ribeirao Preto, Brazil, 14049-900
Chile
Hospital Clinico De La Pointificia Universidad
Santiago, Chile
Hospital Clinico de la Universidad de Chile
Santiago, Chile
Hospital San Jose
Santiago, Chile
Hospital Dr. Sotero Del Rio
Santiago, Chile
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: M Pamela Griffin, M.D. MedImmune LLC
  More Information

Publications:
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00113490     History of Changes
Other Study ID Numbers: MI-CP118
Study First Received: June 8, 2005
Results First Received: April 3, 2013
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
motavizumab, palivizumab, synagis
Rezield, MEDI-524

Additional relevant MeSH terms:
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014