Respiratory Syncytial Virus Infections Clinical Trial
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
Verified date | November 2012 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 24 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Caboolture Clinical Research | Caboolture | Queensland |
Australia | Department of Paediatrics and Child Health, The Canberra Hospital | Garran | Australian Capital Territory |
Australia | University of Queensland, Royal Children's Hospital | Herston | Queensland |
Australia | Peninsula Clinical Research Centre | Kippa-Ring | Queensland |
Australia | Neonatalogy John Hunter Hospital | New Lambton Heights | New South Wales |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | Respiratory Medicine Department, Royal Children's Hospital | Parkville | Victoria |
Chile | Hospital Clinico de la Universidad de Chile | Independencia | Santiago |
Chile | Hospital San Jose | Independencia | Santiago |
Chile | Hospital Clinico de la Pontificia Universidad Catolica de Chile | Santiago | |
Chile | Hospital Clinico San Borja Arriaran | Santiago | |
Chile | Hospital Dr Felix Bulnes Cerda | Santiago | |
Chile | Hospital Dr. Sotero del Rio | Santiago | |
Chile | Hospital Padre Hurtado | Santiago | |
New Zealand | Christchurch Women's Hospital | Christchurch | |
New Zealand | Paediatric Medicine, Dunedin Hospital | Dunedin | |
New Zealand | Department of Paediatrics, Waikato Hospital | Hamilton | |
New Zealand | Kidz First, Middlemore Hospital | Otahuhu | Auckland |
New Zealand | Child Health, Palmerston North Hospital | Palmerston North |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
Australia, Chile, New Zealand,
Fernández 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 pa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Day 0 - Day 150 | Yes | |
Primary | Number of Subjects Reporting Adverse Events (AEs) | Day 0 - Day 150 | Yes | |
Primary | 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. | Day 0 - Day 150 | Yes |
Secondary | The Serum Concentrations of Motavizumab at Day 0 | Day 0 | No | |
Secondary | The Trough Serum Concentrations of Motavizumab at Day 60 | Day 60 | No | |
Secondary | The Trough Serum Concentrations of Motavizumab at Day 150 | Day 150 | No | |
Secondary | The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose | 120-150 days post final dose | No | |
Secondary | The Serum Concentrations of Palivizumab at Day 0 | Day 0 | No | |
Secondary | The Trough Serum Concentrations of Palivizumab at Day 60 | Day 60 | No | |
Secondary | The Trough Serum Concentrations of Palivizumab at Day 150 | Day 150 | No | |
Secondary | The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose | 120-150 days post final dose | No | |
Secondary | 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. | Day 0 | Yes |
Secondary | 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. | Day 60 | Yes |
Secondary | 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. | Day 150 | Yes |
Secondary | 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. | 120 - 150 days post final dose | Yes |
Secondary | 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. | At any time | Yes |
Secondary | 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. | Day 0 | Yes |
Secondary | 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. | Day 60 | Yes |
Secondary | 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. | Day 150 | Yes |
Secondary | 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. | 120 - 150 days post final pose | Yes |
Secondary | 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. | At any time | Yes |
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