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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
260
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.
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.
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.
Department of Paediatrics and Child Health, The Canberra Hospital
Garran, Australian Capital Territory, Australia
Neonatalogy John Hunter Hospital
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)
Time frame: Day 0 - Day 150
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.
Time frame: Day 0 - Day 150
The Serum Concentrations of Motavizumab at Day 0
Time frame: Day 0
The Trough Serum Concentrations of Motavizumab at Day 60
Time frame: Day 60
The Trough Serum Concentrations of Motavizumab at Day 150
Time frame: Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Time frame: 120-150 days post final dose
The Serum Concentrations of Palivizumab at Day 0
Time frame: Day 0
The Trough Serum Concentrations of Palivizumab at Day 60
Time frame: Day 60
The Trough Serum Concentrations of Palivizumab at Day 150
Time frame: Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
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New Lambton Heights, New South Wales, Australia
Caboolture Clinical Research
Caboolture, Queensland, Australia
University of Queensland, Royal Children's Hospital
Herston, Queensland, Australia
Peninsula Clinical Research Centre
Kippa-Ring, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Respiratory Medicine Department, Royal Children's Hospital
Parkville, Victoria, Australia
Hospital Clinico de la Universidad de Chile
Independencia, Santiago Metropolitan, Chile
Hospital San Jose
Independencia, Santiago Metropolitan, Chile
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, Chile
...and 9 more locations
Time frame: 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.
Time frame: Day 0
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.
Time frame: Day 60
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.
Time frame: Day 150
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.
Time frame: 120 - 150 days post final dose
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.
Time frame: At any time
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.
Time frame: Day 0
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.
Time frame: Day 60
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.
Time frame: Day 150
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.
Time frame: 120 - 150 days post final pose
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.
Time frame: At any time