Back to resultsStudy of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Primary Purpose
Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Motavizumab, palivizumab
Palivizumab, motavizumab
Motavizumab
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus, Premature and under 6 mos. of age, Chronic Lung Disease over 6 mos. of age, palivizumab, motavizumab, RSV
Eligibility Criteria
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. 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
Sites / Locations
- Department of Paediatrics and Child Health, The Canberra Hospital
- Neonatalogy John Hunter Hospital
- Caboolture Clinical Research
- University of Queensland, Royal Children's Hospital
- Peninsula Clinical Research Centre
- Women's and Children's Hospital
- Respiratory Medicine Department, Royal Children's Hospital
- Hospital Clinico de la Universidad de Chile
- Hospital San Jose
- Hospital Clinico de la Pontificia Universidad Catolica de Chile
- Hospital Clinico San Borja Arriaran
- Hospital Dr Felix Bulnes Cerda
- Hospital Dr. Sotero del Rio
- Hospital Padre Hurtado
- Kidz First, Middlemore Hospital
- Christchurch Women's Hospital
- Paediatric Medicine, Dunedin Hospital
- Department of Paediatrics, Waikato Hospital
- Child Health, Palmerston North Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Motavizumab followed by Palivizumab
Palivizumab followed by motavizumab
Motavizumab control
Arm Description
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)
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)
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Serious Adverse Events (SAEs)
Number of Subjects Reporting Adverse Events (AEs)
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Secondary Outcome Measures
The Serum Concentrations of Motavizumab at Day 0
The Trough Serum Concentrations of Motavizumab at Day 60
The Trough Serum Concentrations of Motavizumab at Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
The Serum Concentrations of Palivizumab at Day 0
The Trough Serum Concentrations of Palivizumab at Day 60
The Trough Serum Concentrations of Palivizumab at Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
The Immunogenicity of Motavizumab at Day 0
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Motavizumab at Day 60
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Motavizumab at Day 150
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Motavizumab at Any Time
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Palivizumab at Day 0
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Palivizumab at Day 60
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Palivizumab at Day 150
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
The Immunogenicity of Palivizumab at Any Time
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00316264
Brief Title
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a Phase 2, randomized, double-blind study in which motavizumab and palivizumab were administered sequentially to high-risk children during the same RSV season. It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006). Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab. Motavizumab or palivizumab was administered at 15 mg/kg by IM injection every 30 days, for a total of 5 injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
Keywords
Respiratory Syncytial Virus, Premature and under 6 mos. of age, Chronic Lung Disease over 6 mos. of age, palivizumab, motavizumab, RSV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motavizumab followed by Palivizumab
Arm Type
Experimental
Arm Description
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)
Arm Title
Palivizumab followed by motavizumab
Arm Type
Experimental
Arm Description
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)
Arm Title
Motavizumab control
Arm Type
Experimental
Arm Description
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
Intervention Type
Biological
Intervention Name(s)
Motavizumab, palivizumab
Intervention Description
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 Type
Biological
Intervention Name(s)
Palivizumab, motavizumab
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Motavizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame
Day 0 - Day 150
Title
Number of Subjects Reporting Adverse Events (AEs)
Time Frame
Day 0 - Day 150
Title
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Description
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Time Frame
Day 0 - Day 150
Secondary Outcome Measure Information:
Title
The Serum Concentrations of Motavizumab at Day 0
Time Frame
Day 0
Title
The Trough Serum Concentrations of Motavizumab at Day 60
Time Frame
Day 60
Title
The Trough Serum Concentrations of Motavizumab at Day 150
Time Frame
Day 150
Title
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Time Frame
120-150 days post final dose
Title
The Serum Concentrations of Palivizumab at Day 0
Time Frame
Day 0
Title
The Trough Serum Concentrations of Palivizumab at Day 60
Time Frame
Day 60
Title
The Trough Serum Concentrations of Palivizumab at Day 150
Time Frame
Day 150
Title
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Time Frame
120-150 days post final dose
Title
The Immunogenicity of Motavizumab at Day 0
Description
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 0
Title
The Immunogenicity of Motavizumab at Day 60
Description
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 60
Title
The Immunogenicity of Motavizumab at Day 150
Description
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 150
Title
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Description
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
120 - 150 days post final dose
Title
The Immunogenicity of Motavizumab at Any Time
Description
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
At any time
Title
The Immunogenicity of Palivizumab at Day 0
Description
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 0
Title
The Immunogenicity of Palivizumab at Day 60
Description
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 60
Title
The Immunogenicity of Palivizumab at Day 150
Description
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
Day 150
Title
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Description
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
120 - 150 days post final pose
Title
The Immunogenicity of Palivizumab at Any Time
Description
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Time Frame
At any time
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Griffin, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Department of Paediatrics and Child Health, The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Neonatalogy John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Caboolture Clinical Research
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
University of Queensland, Royal Children's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Peninsula Clinical Research Centre
City
Kippa-Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Respiratory Medicine Department, Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Hospital Clinico de la Universidad de Chile
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Hospital San Jose
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Hospital Clinico de la Pontificia Universidad Catolica de Chile
City
Santiago
Country
Chile
Facility Name
Hospital Clinico San Borja Arriaran
City
Santiago
Country
Chile
Facility Name
Hospital Dr Felix Bulnes Cerda
City
Santiago
Country
Chile
Facility Name
Hospital Dr. Sotero del Rio
City
Santiago
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago
Country
Chile
Facility Name
Kidz First, Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand
Facility Name
Christchurch Women's Hospital
City
Christchurch
Country
New Zealand
Facility Name
Paediatric Medicine, Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Department of Paediatrics, Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Child Health, Palmerston North Hospital
City
Palmerston North
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20525274
Citation
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.
Results Reference
result
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Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
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