Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014