Clinical trial NCT00316264: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 260
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Day 0 - Day 150
measure: Number of Subjects Reporting Adverse Events (AEs)
timeFrame: Day 0 - Day 150
measure: Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
timeFrame: Day 0 - Day 150
Secondary outcomes:
measure: The Serum Concentrations of Motavizumab at Day 0
timeFrame: Day 0
measure: The Trough Serum Concentrations of Motavizumab at Day 60
timeFrame: Day 60
measure: The Trough Serum Concentrations of Motavizumab at Day 150
timeFrame: Day 150
measure: The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
timeFrame: 120-150 days post final dose
measure: The Serum Concentrations of Palivizumab at Day 0
timeFrame: Day 0
measure: The Trough Serum Concentrations of Palivizumab at Day 60
timeFrame: Day 60
measure: The Trough Serum Concentrations of Palivizumab at Day 150
timeFrame: Day 150
measure: The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
timeFrame: 120-150 days post final dose
measure: The Immunogenicity of Motavizumab at Day 0
timeFrame: Day 0
measure: The Immunogenicity of Motavizumab at Day 60
timeFrame: Day 60
measure: The Immunogenicity of Motavizumab at Day 150
timeFrame: Day 150
measure: The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
timeFrame: 120 - 150 days post final dose
measure: The Immunogenicity of Motavizumab at Any Time
timeFrame: At any time
measure: The Immunogenicity of Palivizumab at Day 0
timeFrame: Day 0
measure: The Immunogenicity of Palivizumab at Day 60
timeFrame: Day 60
measure: The Immunogenicity of Palivizumab at Day 150
timeFrame: Day 150
measure: The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
timeFrame: 120 - 150 days post final pose
measure: The Immunogenicity of Palivizumab at Any Time
timeFrame: At any time
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Department of Paediatrics and Child Health, The Canberra Hospital
state: Australian Capital Territory
city: New Lambton Heights
country: Australia
facility: Neonatalogy John Hunter Hospital
state: New South Wales
city: Caboolture
country: Australia
facility: Caboolture Clinical Research
state: Queensland
city: Herston
country: Australia
facility: University of Queensland, Royal Children's Hospital
state: Queensland
city: Kippa-Ring
country: Australia
facility: Peninsula Clinical Research Centre
state: Queensland
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Parkville
country: Australia
facility: Respiratory Medicine Department, Royal Children's Hospital
state: Victoria
city: Independencia
country: Chile
facility: Hospital Clinico de la Universidad de Chile
state: Santiago
city: Independencia
country: Chile
facility: Hospital San Jose
state: Santiago
city: Santiago
country: Chile
facility: Hospital Clinico de la Pontificia Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriaran
city: Santiago
country: Chile
facility: Hospital Dr Felix Bulnes Cerda
city: Santiago
country: Chile
facility: Hospital Dr. Sotero del Rio
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Otahuhu
country: New Zealand
facility: Kidz First, Middlemore Hospital
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Women's Hospital
city: Dunedin
country: New Zealand
facility: Paediatric Medicine, Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Department of Paediatrics, Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Child Health, Palmerston North Hospital
Study officials:
affiliation: MedImmune LLC
name: Pamela Griffin, M.D.
role: STUDY_DIRECTOR
References:
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.