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

MedImmune

Status and phase

Completed

Phase 2

Phase 1

Conditions

Motavizumab Administration for a Second Season for RSV Prophylaxis

Treatments

Biological: motavizumab (MEDI-524)

Biological: palivizumab 15 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113490

MI-CP118

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

Under 24 months old

Volunteers

No Healthy Volunteers

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