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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Motavizumab Administration for a Second Season for RSV Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

motavizumab (MEDI-524)

Intervention Type BIOLOGICAL

Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.

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.

Group Type ACTIVE_COMPARATOR

palivizumab 15 mg/kg

Intervention Type BIOLOGICAL

Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.

Interventions

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motavizumab (MEDI-524)

Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.

Intervention Type BIOLOGICAL

palivizumab 15 mg/kg

Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.

Intervention Type BIOLOGICAL

Other Intervention Names

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motavizumab Rezield synagis

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No