Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00316264
First received: April 18, 2006
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Syncytial Virus Infections Chronic Lung Disease and <= 24 Months of Age or Premature With Gestational Age <=35 Weeks and <=6 Months of Age |
Biological: Motavizumab, palivizumab Biological: Palivizumab, motavizumab Biological: Motavizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Respiratory Syncytial Virus Infections
Drug Information available for:
Palivizumab
U.S. FDA Resources
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Day 0 - Day 150 ] [ Designated as safety issue: Yes ]
- Number of Subjects Reporting Adverse Events (AEs) [ Time Frame: Day 0 - Day 150 ] [ Designated as safety issue: Yes ]
- Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. [ Time Frame: Day 0 - Day 150 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Motavizumab at Day 60 [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Motavizumab at Day 150 [ Time Frame: Day 150 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose [ Time Frame: 120-150 days post final dose ] [ Designated as safety issue: No ]
- The Serum Concentrations of Palivizumab at Day 0 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Palivizumab at Day 60 [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Palivizumab at Day 150 [ Time Frame: Day 150 ] [ Designated as safety issue: No ]
- The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose [ Time Frame: 120-150 days post final dose ] [ Designated as safety issue: No ]
- The Immunogenicity of Motavizumab at Day 0 [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 60 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 150 ] [ Designated as safety issue: Yes ]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 [ Time Frame: 120 - 150 days post final dose ] [ Designated as safety issue: Yes ]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 [ Time Frame: At any time ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 60 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 150 ] [ Designated as safety issue: Yes ]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 [ Time Frame: 120 - 150 days post final pose ] [ Designated as safety issue: Yes ]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 [ Time Frame: At any time ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 260 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Biological: 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.
|
|
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)
|
Biological: 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.
|
|
Experimental: Motavizumab control
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Biological: 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.
|
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.
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316264
Locations
| Australia, Australian Capital Territory | |
| Department of Paediatrics and Child Health, The Canberra Hospital | |
| Garran, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Neonatalogy John Hunter Hospital | |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Australia, Queensland | |
| Caboolture Clinical Research | |
| Caboolture, Queensland, Australia, 4510 | |
| University of Queensland, Royal Children's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Peninsula Clinical Research Centre | |
| Kippa-Ring, Queensland, Australia, 4021 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Respiratory Medicine Department, Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Chile | |
| Hospital San Jose | |
| Independencia, Santiago, Chile | |
| Hospital Clinico de la Universidad de Chile | |
| Independencia, Santiago, Chile | |
| Hospital Clinico de la Pontificia Universidad Catolica de Chile | |
| Santiago, Chile | |
| Hospital Dr. Sotero del Rio | |
| Santiago, Chile | |
| Hospital Dr Felix Bulnes Cerda | |
| Santiago, Chile | |
| Hospital Clinico San Borja Arriaran | |
| Santiago, Chile | |
| Hospital Padre Hurtado | |
| Santiago, Chile | |
| New Zealand | |
| Kidz First, Middlemore Hospital | |
| Otahuhu, Auckland, New Zealand | |
| Christchurch Women's Hospital | |
| Christchurch, New Zealand | |
| Paediatric Medicine, Dunedin Hospital | |
| Dunedin, New Zealand | |
| Department of Paediatrics, Waikato Hospital | |
| Hamilton, New Zealand | |
| Child Health, Palmerston North Hospital | |
| Palmerston North, New Zealand | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Pamela Griffin, M.D. | MedImmune LLC |
More Information
Publications:
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00316264 History of Changes |
| Other Study ID Numbers: | MI-CP127 |
| Study First Received: | April 18, 2006 |
| Results First Received: | October 3, 2012 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MedImmune LLC:
|
Respiratory Syncytial Virus Premature and under 6 mos. of age Chronic Lung Disease over 6 mos. of age |
palivizumab motavizumab RSV |
Additional relevant MeSH terms:
|
Lung Diseases Respiratory Syncytial Virus Infections Virus Diseases Respiratory Tract Diseases Pneumovirus Infections Paramyxoviridae Infections Mononegavirales Infections |
RNA Virus Infections Palivizumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013