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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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MI-CP110
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - motavizumab (MEDI-524)
Other interventions - 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
Other interventions: motavizumab (MEDI-524)
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Other interventions: palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of RSV Hospitalization (Includes Deaths by RSV)
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Assessment method [1]
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RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
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Timepoint [1]
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Days 0 - 150
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Primary outcome [2]
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Number of Participants Reporting Any Adverse Events (AEs)
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Assessment method [2]
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Number of participants reporting one or more AEs
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Timepoint [2]
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Days 0 - 150
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Primary outcome [3]
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Number of Participants Reporting Any Related AEs
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Assessment method [3]
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Number of participants reporting one or more AEs considered related to study drug by the investigator
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Timepoint [3]
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Days 0 - 150
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Primary outcome [4]
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Number of Participants Reporting Any Serious Adverse Events (SAEs)
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Assessment method [4]
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Number of participants reporting one or more SAEs
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Timepoint [4]
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Days 0 - 150
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Primary outcome [5]
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Number of Participants Reporting Any Related SAEs
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Assessment method [5]
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Number of participants reporting one or more SAEs considered related to study drug by the investigator
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Timepoint [5]
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Days 0 - 150
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Primary outcome [6]
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Number of Participants Reporting AEs by Highest Severity Grade
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Assessment method [6]
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Adverse events events were graded by severity; Level 1, 2, 3, or 4
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Timepoint [6]
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Days 0 - 150
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Primary outcome [7]
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Number of Participants Who Discontinued Study Drug Due to AEs
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Assessment method [7]
0
0
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Timepoint [7]
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Days 0 - 150
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Primary outcome [8]
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Number of Participants Who Died
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Assessment method [8]
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0
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Timepoint [8]
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Days 0 - 150
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Primary outcome [9]
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Number of Participants Reporting Changes in Vital Signs From Baseline
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Assessment method [9]
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Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
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Timepoint [9]
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Days 0 - 150
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Secondary outcome [1]
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The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
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Assessment method [1]
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LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.
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Timepoint [1]
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Day 0 - 150
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Secondary outcome [2]
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The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
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Assessment method [2]
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The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.
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Timepoint [2]
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Days 0 - 150
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Secondary outcome [3]
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The Incidence of Medically-attended Otitis Media (OM) Infections
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Assessment method [3]
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Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.
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Timepoint [3]
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Days 0 - 150
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Secondary outcome [4]
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The Frequency of Prescribed Antibiotics for Medically-attended LRI
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Assessment method [4]
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The average number of presciptions per event per subject was summarized for each treatment group.
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Timepoint [4]
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Days 0 - 150
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Secondary outcome [5]
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The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
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Assessment method [5]
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The average number of presciptions per event per subject was summarized for each treatment group.
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Timepoint [5]
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Days 0 - 150
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Secondary outcome [6]
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The Number of Participants With Anti-motavizumab Antibodies
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Assessment method [6]
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Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.
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Timepoint [6]
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Day 0 - 120
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Secondary outcome [7]
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The Serum Concentrations of Motavizumab at Day 0
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Assessment method [7]
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Mean serum concentrations of motavizumab at Day 0
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Timepoint [7]
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Day 0
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Secondary outcome [8]
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The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
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Assessment method [8]
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Mean serum concentrations of motavizumab at 30 days post Dose 1
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Timepoint [8]
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30 days post Dose 1
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Secondary outcome [9]
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The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
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Assessment method [9]
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Mean serum concentrations of motavizumab at 30 days post Dose 2
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Timepoint [9]
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30 days post Dose 2
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Secondary outcome [10]
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The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
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Assessment method [10]
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Mean serum concentrations of motavizumab at 30 days post Dose 3
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Timepoint [10]
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30 days post Dose 3
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Secondary outcome [11]
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The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
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Assessment method [11]
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Mean serum concentrations of motavizumab at 30 days post Dose 4
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Timepoint [11]
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30 days post Dose 4
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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)
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Minimum age
No limit
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Maximum age
24
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2006
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Sample size
Target
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Accrual to date
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Final
6635
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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John Hunter Children's Hospital - New Lambton
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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Royal Children's Hospital (Brisbane) - Herston
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Recruitment hospital [5]
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Peninsula Clinical Research Centre - Kippa-Ring
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Recruitment hospital [6]
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Mater Mothers Hospital Raymond Terrace - South Brisbane
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Recruitment hospital [7]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [8]
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Royal Children's Hospital (Melbourne) - Parkville
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Recruitment hospital [9]
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Princess Margaret Children's Hospital - Subiaco
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Recruitment hospital [10]
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Women's and Children's Hospital - North Adelaide
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2305 - New Lambton
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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4021 - Kippa-Ring
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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7000 - Hobart
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Recruitment postcode(s) [8]
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3052 - Parkville
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Recruitment postcode(s) [9]
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6008 - Subiaco
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Recruitment postcode(s) [10]
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5006 - North Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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State/province [7]
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Hawaii
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Illinois
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Graz
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Tulln
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Campinas
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Canada
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Canada
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Canada
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Canada
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Chile
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Independencia
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Chile
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Puente Alto
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Chile
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Quinta Normal
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Chile
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Santiago
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Czech Republic
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Ceske Budejovice
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Czech Republic
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Hradec Kralove
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Czech Republic
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Most
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Olomouc
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Ostrava
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Czech Republic
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Plzen-Bory
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Plzen-Lochotin
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Praha 2
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Czech Republic
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Czech Republic
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Zlin
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Denmark
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Herning
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Denmark
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Hillerod
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Denmark
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Hvidovre
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Denmark
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Viborg
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Germany
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Israel
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Natanya
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Israel
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Israel
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Rehovot
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Israel
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Israel
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Israel
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Tiberia
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Italy
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Italy
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Italy
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Bolzano
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Italy
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Brescia
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Italy
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Cuneo
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Italy
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Foggia
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Italy
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Italy
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Italy
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Messina
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Italy
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Monza
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Italy
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Italy
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Izmir
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United Kingdom
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Birmingham
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Sheffield
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United Kingdom
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Winchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Ethics approval
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Summary
Brief summary
The primary objective of this study was to compare the safety and efficacy of motavizumab to
palivizumab when administered monthly by intramuscular (IM) injection for the reduction of
the incidence of RSV hospitalization among children at high risk for serious RSV disease. A
secondary objective was to compare the incidence of medically-attended lower respiratory
infections (LRIs) between treatment groups.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00129766
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Public notes
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Contacts
Principal investigator
Name
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M Pamela Griffin, MD
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Address
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MedImmune LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00129766
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