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

November 13, 2012 updated by: MedImmune LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Department of Paediatrics and Child Health, The Canberra Hospital
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • Neonatalogy John Hunter Hospital
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • Caboolture Clinical Research
      • Herston, Queensland, Australia, 4029
        • University of Queensland, Royal Children's Hospital
      • Kippa-Ring, Queensland, Australia, 4021
        • Peninsula Clinical Research Centre
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Respiratory Medicine Department, Royal Children's Hospital
  • Chile
      • Santiago, Chile
        • Hospital Clinico de la Pontificia Universidad Catolica de Chile
      • Santiago, Chile
        • Hospital Dr. Sotero del Rio
      • Santiago, Chile
        • Hospital Clinico San Borja Arriarán
      • Santiago, Chile
        • Hospital Padre Hurtado
      • Santiago, Chile
        • Hospital Dr Felix Bulnes Cerda
    • Santiago
      • Independencia, Santiago, Chile
        • Hospital Clínico de la Universidad de Chile
      • Independencia, Santiago, Chile
        • Hospital San Jose
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Women's Hospital
      • Dunedin, New Zealand
        • Paediatric Medicine, Dunedin Hospital
      • Hamilton, New Zealand
        • Department of Paediatrics, Waikato Hospital
      • Palmerston North, New Zealand
        • Child Health, Palmerston North Hospital
    • Auckland
      • Otahuhu, Auckland, New Zealand
        • Kidz First, Middlemore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: Day 0 - Day 150
Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)
Time Frame: Day 0 - Day 150
Day 0 - Day 150
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Time Frame: Day 0 - Day 150
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Serum Concentrations of Motavizumab at Day 0
Time Frame: Day 0
Day 0
The Trough Serum Concentrations of Motavizumab at Day 60
Time Frame: Day 60
Day 60
The Trough Serum Concentrations of Motavizumab at Day 150
Time Frame: Day 150
Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Time Frame: 120-150 days post final dose
120-150 days post final dose
The Serum Concentrations of Palivizumab at Day 0
Time Frame: Day 0
Day 0
The Trough Serum Concentrations of Palivizumab at Day 60
Time Frame: Day 60
Day 60
The Trough Serum Concentrations of Palivizumab at Day 150
Time Frame: Day 150
Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Time Frame: 120-150 days post final dose
120-150 days post final dose
The Immunogenicity of Motavizumab at Day 0
Time Frame: 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
The Immunogenicity of Motavizumab at Day 60
Time Frame: 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
The Immunogenicity of Motavizumab at Day 150
Time Frame: 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
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Time Frame: 120 - 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
The Immunogenicity of Motavizumab at Any Time
Time Frame: 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
The Immunogenicity of Palivizumab at Day 0
Time Frame: 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
The Immunogenicity of Palivizumab at Day 60
Time Frame: 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
The Immunogenicity of Palivizumab at Day 150
Time Frame: 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
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Time Frame: 120 - 150 days post final pose
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
The Immunogenicity of Palivizumab at Any Time
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pamela Griffin, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-CP127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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