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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00316264




Registration number
NCT00316264
Ethics application status
Date submitted
18/04/2006
Date registered
20/04/2006
Date last updated
11/12/2012

Titles & IDs
Public title
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Scientific title
A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab When Administered in the Same Season
Secondary ID [1] 0 0
MI-CP127
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Chronic Lung Disease and <= 24 Months of Age or 0 0
Premature With Gestational Age <=35 Weeks and <=6 Months of Age 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, palivizumab
Treatment: Other - Palivizumab, motavizumab
Treatment: Other - Motavizumab

Experimental: Motavizumab followed by Palivizumab - 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)

Experimental: Palivizumab followed by motavizumab - 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Experimental: Motavizumab control - 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)


Treatment: Other: Motavizumab, palivizumab
Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.

Treatment: Other: Palivizumab, motavizumab
Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.

Treatment: Other: Motavizumab
Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Day 0 - Day 150
Primary outcome [2] 0 0
Number of Subjects Reporting Adverse Events (AEs)
Timepoint [2] 0 0
Day 0 - Day 150
Primary outcome [3] 0 0
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Timepoint [3] 0 0
Day 0 - Day 150
Secondary outcome [1] 0 0
The Serum Concentrations of Motavizumab at Day 0
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
The Trough Serum Concentrations of Motavizumab at Day 60
Timepoint [2] 0 0
Day 60
Secondary outcome [3] 0 0
The Trough Serum Concentrations of Motavizumab at Day 150
Timepoint [3] 0 0
Day 150
Secondary outcome [4] 0 0
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Timepoint [4] 0 0
120-150 days post final dose
Secondary outcome [5] 0 0
The Serum Concentrations of Palivizumab at Day 0
Timepoint [5] 0 0
Day 0
Secondary outcome [6] 0 0
The Trough Serum Concentrations of Palivizumab at Day 60
Timepoint [6] 0 0
Day 60
Secondary outcome [7] 0 0
The Trough Serum Concentrations of Palivizumab at Day 150
Timepoint [7] 0 0
Day 150
Secondary outcome [8] 0 0
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Timepoint [8] 0 0
120-150 days post final dose
Secondary outcome [9] 0 0
The Immunogenicity of Motavizumab at Day 0
Timepoint [9] 0 0
Day 0
Secondary outcome [10] 0 0
The Immunogenicity of Motavizumab at Day 60
Timepoint [10] 0 0
Day 60
Secondary outcome [11] 0 0
The Immunogenicity of Motavizumab at Day 150
Timepoint [11] 0 0
Day 150
Secondary outcome [12] 0 0
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Timepoint [12] 0 0
120 - 150 days post final dose
Secondary outcome [13] 0 0
The Immunogenicity of Motavizumab at Any Time
Timepoint [13] 0 0
At any time
Secondary outcome [14] 0 0
The Immunogenicity of Palivizumab at Day 0
Timepoint [14] 0 0
Day 0
Secondary outcome [15] 0 0
The Immunogenicity of Palivizumab at Day 60
Timepoint [15] 0 0
Day 60
Secondary outcome [16] 0 0
The Immunogenicity of Palivizumab at Day 150
Timepoint [16] 0 0
Day 150
Secondary outcome [17] 0 0
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Timepoint [17] 0 0
120 - 150 days post final pose
Secondary outcome [18] 0 0
The Immunogenicity of Palivizumab at Any Time
Timepoint [18] 0 0
At any time

Eligibility
Key inclusion criteria
* The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
* The child must be in general good health at the time of study entry.
* The child's parent(s)/legal guardian must provide written informed consent.
* The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
* Parent(s)/legal guardian of patient must have available telephone access.
Minimum age
No limit
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
* Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
* Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
* Evidence of infection with hepatitis A, B, or C virus
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
* Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
* Acute illness or progressive clinical disorder
* Active infection, including acute RSV infection, at the time of enrollment
* Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
* Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
* Previous participation in a clinical trial of motavizumab
* Currently participating in any investigational study

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 2
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
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Department of Paediatrics and Child Health, The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Neonatalogy John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Caboolture Clinical Research - Caboolture
Recruitment hospital [4] 0 0
University of Queensland, Royal Children's Hospital - Herston
Recruitment hospital [5] 0 0
Peninsula Clinical Research Centre - Kippa-Ring
Recruitment hospital [6] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [7] 0 0
Respiratory Medicine Department, Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4510 - Caboolture
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Dunedin
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hamilton
Country [6] 0 0
New Zealand
State/province [6] 0 0
Palmerston North

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab.
Trial website
https://clinicaltrials.gov/study/NCT00316264
Trial related presentations / publications
Fernandez P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA; Motavizumab Study Group. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr. 2010 Jun 3;10:38. doi: 10.1186/1471-2431-10-38.
Public notes

Contacts
Principal investigator
Name 0 0
Pamela Griffin, M.D.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00316264