A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants

The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

Study Overview

• Status: Withdrawn
• Conditions: Wheezing
• Intervention / Treatment: Biological: Motavizumab; Other: Placebo

Detailed Description

The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female infants born at 32 & 1/7 - 35 & 0/7 weeks GA, determined according to available medical records
• Chronological age of <6 months of age at randomization
• In good health, in the opinion of the investigator

• Not more than one of the following AAP-defined risk factors:

  1. Childcare attendance
  2. School-aged siblings
  3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
• Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
• Written informed consent obtained from the subject's parent(s) or legal guardian

Exclusion Criteria:

• Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
• Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
• Congenital abnormalities of the airways
• Severe neuromuscular disease, as determined by the investigator
• Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
• Eligible for prophylaxis based on local medical standards and guidelines at participating sites
• Known immunodeficiency
• Previous or current diagnosis of an upper or lower respiratory infection by a medical professional
• Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses
• Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)
• Any illness or condition that would preclude long-term survival
• Participation in a trial or an investigational agent for RSV prophylaxis or therapy
• Inability to be followed through their 3rd birthday

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Other: Placebo; 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
Experimental: 1; Motavizumab	Biological: Motavizumab; 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections; Other Names: MEDI-524

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of serious early childhood wheezing episodes	Between 2nd and 3rd birthdays

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of medically-attended lower respiratory tract wheezing events	During 2nd and 3rd birthday
Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age	From randomization through 3 yrs.
Incidence of serious RSV disease	Through Day 150

Collaborators and Investigators

• Sponsor: MedImmune LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: March 4, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Good health
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: MI-CP169