A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
Primary Purpose
Wheezing
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Motavizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wheezing focused on measuring Good health
Eligibility Criteria
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:
- Childcare attendance
- School-aged siblings
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Motavizumab
Placebo
Outcomes
Primary Outcome Measures
The incidence of serious early childhood wheezing episodes
Secondary Outcome Measures
Frequency of medically-attended lower respiratory tract wheezing events
Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age
Incidence of serious RSV disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00628303
Brief Title
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study never officially opened for enrollment
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
MedImmune LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezing
Keywords
Good health
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Motavizumab
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Motavizumab
Other Intervention Name(s)
MEDI-524
Intervention Description
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
Primary Outcome Measure Information:
Title
The incidence of serious early childhood wheezing episodes
Time Frame
Between 2nd and 3rd birthdays
Secondary Outcome Measure Information:
Title
Frequency of medically-attended lower respiratory tract wheezing events
Time Frame
During 2nd and 3rd birthday
Title
Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age
Time Frame
From randomization through 3 yrs.
Title
Incidence of serious RSV disease
Time Frame
Through Day 150
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Childcare attendance
School-aged siblings
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
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
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