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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00129766




Registration number
NCT00129766
Ethics application status
Date submitted
10/08/2005
Date registered
12/08/2005
Date last updated
28/08/2013

Titles & IDs
Public title
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Scientific title
A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children
Secondary ID [1] 0 0
MI-CP110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - motavizumab (MEDI-524)
Treatment: Other - palivizumab

Active comparator: palivizumab - 15 mg/kg administered intramuscularly for 5 monthly doses

Experimental: motavizumab (MEDI-524) - 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses


Treatment: Other: motavizumab (MEDI-524)
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Treatment: Other: palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of RSV Hospitalization (Includes Deaths by RSV)
Timepoint [1] 0 0
Days 0 - 150
Primary outcome [2] 0 0
Number of Participants Reporting Any Adverse Events (AEs)
Timepoint [2] 0 0
Days 0 - 150
Primary outcome [3] 0 0
Number of Participants Reporting Any Related AEs
Timepoint [3] 0 0
Days 0 - 150
Primary outcome [4] 0 0
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Days 0 - 150
Primary outcome [5] 0 0
Number of Participants Reporting Any Related SAEs
Timepoint [5] 0 0
Days 0 - 150
Primary outcome [6] 0 0
Number of Participants Reporting AEs by Highest Severity Grade
Timepoint [6] 0 0
Days 0 - 150
Primary outcome [7] 0 0
Number of Participants Who Discontinued Study Drug Due to AEs
Timepoint [7] 0 0
Days 0 - 150
Primary outcome [8] 0 0
Number of Participants Who Died
Timepoint [8] 0 0
Days 0 - 150
Primary outcome [9] 0 0
Number of Participants Reporting Changes in Vital Signs From Baseline
Timepoint [9] 0 0
Days 0 - 150
Secondary outcome [1] 0 0
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
Timepoint [1] 0 0
Day 0 - 150
Secondary outcome [2] 0 0
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
Timepoint [2] 0 0
Days 0 - 150
Secondary outcome [3] 0 0
The Incidence of Medically-attended Otitis Media (OM) Infections
Timepoint [3] 0 0
Days 0 - 150
Secondary outcome [4] 0 0
The Frequency of Prescribed Antibiotics for Medically-attended LRI
Timepoint [4] 0 0
Days 0 - 150
Secondary outcome [5] 0 0
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
Timepoint [5] 0 0
Days 0 - 150
Secondary outcome [6] 0 0
The Number of Participants With Anti-motavizumab Antibodies
Timepoint [6] 0 0
Day 0 - 120
Secondary outcome [7] 0 0
The Serum Concentrations of Motavizumab at Day 0
Timepoint [7] 0 0
Day 0
Secondary outcome [8] 0 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
Timepoint [8] 0 0
30 days post Dose 1
Secondary outcome [9] 0 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
Timepoint [9] 0 0
30 days post Dose 2
Secondary outcome [10] 0 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
Timepoint [10] 0 0
30 days post Dose 3
Secondary outcome [11] 0 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
Timepoint [11] 0 0
30 days post Dose 4

Eligibility
Key inclusion criteria
* 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization

OR:

* 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)
Minimum age
No limit
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
* Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
* Life expectancy < 6 months
* Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
* Known renal impairment
* Known hepatic dysfunction
* Chronic seizure or evolving or unstable neurologic disorder
* Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
* Known immunodeficiency
* Mother with HIV infection (unless the child has been proven to be not infected)
* Known allergy to Ig products
* Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
* Previous receipt of RSV vaccines
* Participation in other investigational drug product studies

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
6635
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Children's Hospital (Brisbane) - Herston
Recruitment hospital [5] 0 0
Peninsula Clinical Research Centre - Kippa-Ring
Recruitment hospital [6] 0 0
Mater Mothers Hospital Raymond Terrace - South Brisbane
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Royal Children's Hospital (Melbourne) - Parkville
Recruitment hospital [9] 0 0
Princess Margaret Children's Hospital - Subiaco
Recruitment hospital [10] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment postcode(s) [10] 0 0
5006 - North Adelaide
Recruitment outside Australia
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State/province [199] 0 0
Eskilstuna
Country [200] 0 0
Sweden
State/province [200] 0 0
Goteborg
Country [201] 0 0
Sweden
State/province [201] 0 0
Stockholm
Country [202] 0 0
Sweden
State/province [202] 0 0
Uppsala
Country [203] 0 0
Turkey
State/province [203] 0 0
Ankara
Country [204] 0 0
Turkey
State/province [204] 0 0
Izmir
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Birmingham
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Dumfries
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Dundee
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Gillingham Kent
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Hants
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Leeds
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Middlesborough
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Nottingham
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Sheffield
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Winchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M Pamela Griffin, MD
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00129766