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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Withdrawn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

About this trial

This is an interventional treatment trial for Wheezing focused on measuring Good health

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

NCT ID

NCT00628303

First Posted

February 20, 2008

Last Updated

July 30, 2012

Sponsor

MedImmune LLC

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

Arm Type

Experimental

Arm Description

Motavizumab

Arm Title

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

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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