A Phase 3 Trial of the Effect of Motavizumab Prophylaxis... | NCT00628303

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

NCT00628303

Sponsor

MedImmune LLC

Status

Withdrawn

Last Update Posted

Aug 1, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Wheezing

Interventions

Motavizumab
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never officially opened for enrollment

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Feb 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Mar 4, 2008

First Posted Date

Mar 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2012

Last Update Posted Date

Aug 1, 2012Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1	Experimental	Motavizumab	Biological: Motavizumab
2	Placebo Comparator	Placebo	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Motavizumab	Biological	15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections	1

Measure	Description	Time Frame
The incidence of serious early childhood wheezing episodes		Between 2nd and 3rd birthdays

Measure	Description	Time Frame
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.

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms