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

April 3, 2013 updated by: MedImmune LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 90610-000
        • Pontificia Universidade Catolica Do Rio Grande
      • Ribeirao Preto, Brazil, 14049-900
        • Hospital Das Clinicas Da Faculdade
  • Chile
      • Santiago, Chile
        • Hospital Dr. Sótero del Río
      • Santiago, Chile
        • Hospital San José
      • Santiago, Chile
        • Hospital Clinico De La Pointificia Universidad
      • Santiago, Chile
        • Hospital Clinico de la Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • synagis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Exhibiting Anti-motavizumab Antibodies
Time Frame: Day 0 through 120 days post final dose
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.
Day 0 through 120 days post final dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Adverse Events (AEs)
Time Frame: Day 0 through 30 days post final dose
Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
Day 0 through 30 days post final dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: Day 0 through 30 days post final dose
Assessments of SAEs were made by clinical investigators according to the protocol.
Day 0 through 30 days post final dose
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations
Time Frame: Day 0 through 30 days post final dose
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.
Day 0 through 30 days post final dose
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
Mean serum concentration.
Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: M Pamela Griffin, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

June 8, 2005

First Submitted That Met QC Criteria

June 8, 2005

First Posted (Estimate)

June 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-CP118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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