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

Phase 1

Completed

• Conditions: Motavizumab Administration for a Second Season for RSV Prophylaxis
• Interventions: Biological: motavizumab (MEDI-524); Biological: palivizumab 15 mg/kg

• Registration Number: NCT00113490
• Lead Sponsor: MedImmune LLC

Brief Summary

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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-08
• Study First Submitted QC: 2005-06-08
• Study First Posted: 2005-06-09
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2013-04
• Results First Submitted: 2013-04-03
• Results First Submitted QC: 2013-04-03
• Last Update Submitted: 2013-04-03
• Results First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motavizumab (MEDI-524) 15 mg/kg	motavizumab (MEDI-524)	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.
palivizumab 15 mg/kg	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Exhibiting Anti-motavizumab Antibodies	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Adverse Events (AEs)	Day 0 through 30 days post final dose	Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
Number of Subjects Reporting Serious Adverse Events (SAEs)	Day 0 through 30 days post final dose	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	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.
Motavizumab Serum Concentrations at Each Data Collection Visit	Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose	Mean serum concentration.

Trial Locations

Locations (6)

Hospital Dr. Sotero Del Rio; 🇨🇱 Santiago, Chile

Hospital San Jose; 🇨🇱 Santiago, Chile

Pontificia Universidade Catolica Do Rio Grande; 🇧🇷 Porto Alegre, Brazil

Hospital Das Clinicas Da Faculdade; 🇧🇷 Ribeirao Preto, Brazil

Hospital Clinico De La Pointificia Universidad; 🇨🇱 Santiago, Chile

Hospital Clinico de la Universidad de Chile; 🇨🇱 Santiago, Chile