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

NCT ID: NCT00316264

Last Updated: 2012-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Motavizumab, palivizumab

Intervention Type: BIOLOGICAL

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 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)

Group Type: EXPERIMENTAL

Palivizumab, motavizumab

Intervention Type: BIOLOGICAL

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 control

5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Group Type: EXPERIMENTAL

Motavizumab

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Griffin, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Department of Paediatrics and Child Health, The Canberra Hospital

Garran, Australian Capital Territory, Australia

Neonatalogy John Hunter Hospital

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

Hospital Clinico San Borja Arriaran

Santiago, , Chile

Hospital Dr Felix Bulnes Cerda

Santiago, , Chile

Hospital Dr. Sotero del Rio

Santiago, , Chile

Hospital Padre Hurtado

Santiago, , Chile

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

Countries

Brazil; Australia; Chile; New Zealand

References

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.

Reference Type: RESULT

PMID: 20525274 (View on PubMed)

Other Identifiers

MI-CP127

Identifier Type: -

Identifier Source: org_study_id