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

This study has been withdrawn prior to enrollment.
(Study never officially opened for enrollment)
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00628303
First received: February 20, 2008
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Wheezing
Biological: Motavizumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The incidence of serious early childhood wheezing episodes [ Time Frame: Between 2nd and 3rd birthdays ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of medically-attended lower respiratory tract wheezing events [ Time Frame: During 2nd and 3rd birthday ] [ Designated as safety issue: No ]
  • Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age [ Time Frame: From randomization through 3 yrs. ] [ Designated as safety issue: No ]
  • Incidence of serious RSV disease [ Time Frame: Through Day 150 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MEDI-524
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

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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hasan S. Jafri, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00628303     History of Changes
Other Study ID Numbers: MI-CP169
Study First Received: February 20, 2008
Last Updated: July 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Good health

ClinicalTrials.gov processed this record on September 18, 2014