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

Phase 2

Completed

• 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
• Interventions: Biological: Motavizumab, palivizumab; Biological: Palivizumab, motavizumab; Biological: Motavizumab

• Registration Number: NCT00316264
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Results First Submitted: 2012-10-03
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-13
• Last Update Submitted: 2012-11-13
• Results First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motavizumab followed by Palivizumab	Motavizumab, 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)
Palivizumab followed by motavizumab	Palivizumab, 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)
Motavizumab control	Motavizumab	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Serious Adverse Events (SAEs)	Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)	Day 0 - Day 150
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.	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.

Secondary Outcome Measures

Name	Time	Method
The Serum Concentrations of Motavizumab at Day 0	Day 0
The Trough Serum Concentrations of Motavizumab at Day 60	Day 60
The Trough Serum Concentrations of Motavizumab at Day 150	Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose	120-150 days post final dose
The Serum Concentrations of Palivizumab at Day 0	Day 0
The Trough Serum Concentrations of Palivizumab at Day 60	Day 60
The Trough Serum Concentrations of Palivizumab at Day 150	Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose	120-150 days post final dose
The Immunogenicity of Motavizumab at Day 0	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.
The Immunogenicity of Motavizumab at Day 60	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.
The Immunogenicity of Motavizumab at Day 150	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.
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose	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.
The Immunogenicity of Motavizumab at Any Time	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.
The Immunogenicity of Palivizumab at Day 0	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.
The Immunogenicity of Palivizumab at Day 60	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.
The Immunogenicity of Palivizumab at Day 150	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.
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose	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.
The Immunogenicity of Palivizumab at Any Time	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.

Trial Locations

Locations (19)

Neonatalogy John Hunter Hospital; 🇦🇺 New Lambton Heights, New South Wales, Australia

Hospital San Jose; 🇨🇱 Independencia, Santiago, Chile

Hospital Padre Hurtado; 🇨🇱 Santiago, Chile

Department of Paediatrics, Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Hospital Clinico San Borja Arriaran; 🇨🇱 Santiago, Chile

Hospital Dr Felix Bulnes Cerda; 🇨🇱 Santiago, Chile

Hospital Dr. Sotero del Rio; 🇨🇱 Santiago, Chile

Hospital Clinico de la Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Chile

Christchurch Women's Hospital; 🇳🇿 Christchurch, New Zealand

Paediatric Medicine, Dunedin Hospital; 🇳🇿 Dunedin, New Zealand

Child Health, Palmerston North Hospital; 🇳🇿 Palmerston North, New Zealand

University of Queensland, Royal Children's Hospital; 🇦🇺 Herston, Queensland, Australia

Women's and Children's Hospital; 🇦🇺 North Adelaide, South Australia, Australia

Peninsula Clinical Research Centre; 🇦🇺 Kippa-Ring, Queensland, Australia

Hospital Clinico de la Universidad de Chile; 🇨🇱 Independencia, Santiago, Chile

Kidz First, Middlemore Hospital; 🇳🇿 Otahuhu, Auckland, New Zealand

Department of Paediatrics and Child Health, The Canberra Hospital; 🇦🇺 Garran, Australian Capital Territory, Australia

Caboolture Clinical Research; 🇦🇺 Caboolture, Queensland, Australia

Respiratory Medicine Department, Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia