Clinical trial NCT00628303: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Wheezing
Keywords: Good health
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: The incidence of serious early childhood wheezing episodes
timeFrame: Between 2nd and 3rd birthdays
Secondary outcomes:
measure: Frequency of medically-attended lower respiratory tract wheezing events
timeFrame: During 2nd and 3rd birthday
measure: Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age
timeFrame: From randomization through 3 yrs.
measure: Incidence of serious RSV disease
timeFrame: Through Day 150
Other outcomes:
Locations:
Study officials:
References: