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

Phase 3

Withdrawn

• Conditions: Wheezing
• Interventions: Biological: Motavizumab; Other: Placebo

• Registration Number: NCT00628303
• Lead Sponsor: MedImmune LLC

Brief Summary

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.

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 Timeline

• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-05
• Study Start: 2010-10
• Primary Completion: 2011-02
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Motavizumab	Motavizumab
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The incidence of serious early childhood wheezing episodes	Between 2nd and 3rd birthdays

Secondary Outcome Measures

Name	Time	Method
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