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

Condition(s) targeted: Respiratory Syncytial Virus Infections; Chronic Lung Disease

Intervention: MEDI-524 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Pamela Griffin, M.D., Study Director, Affiliation: MedImmune LLC

This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab will be administered to high-risk children during the same respiratory syncytial virus (RSV) season. It is anticipated that approximately 240 children (80 in each group) will be enrolled from the southern hemisphere during the upcoming RSV season (2006).

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study

Primary outcome: The safety and tolerability of motavizumab and palivizumab when received in the same RSV season will be assessed primarily by summarizing adverse events through 30 days post last dose.

Secondary outcome: Immunogenicity and pharmacokinetics of motavizumab and palivizumab received in the same RSV season will be evaluated by summarizing serum ELISA-binding activity at each time point and overall and by serum concentrations, respectively.

Detailed description: This is a Phase 2, randomized, double-blind study in which motavizumab and palivizumab will be administered to high-risk children during the same RSV season. It is anticipated that approximately 240 children (80 in each group) will be enrolled from the southern hemisphere during the upcoming RSV season (2006). Children will be randomized into one of three regimens in a 1: 1:1 ratio; the first group will receive 2 doses of motavizumab followed by 3 doses of palivizumab; the second group will receive 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group will receive 5 doses of motavizumab. Motavizumab or palivizumab will be administered at 15 mg/kg by IM injection every 30 days, for a total of 5 injections.

Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.

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

Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, Chile

Hospital Dr. Sotero del Rio, Santiago, Chile

Hospital Padre Hurtado, Santiago, Chile

Hospital Clinico San Borja Arriaran, Santiago, Chile

Hospital Dr Felix Bulnes Cerda, Santiago, Chile

Child Health, Palmerston North Hospital, Palmerston North, New Zealand

Department of Paediatrics, Waikato Hospital, Hamilton, New Zealand

Paediatric Medicine, Dunedin Hospital, Dunedin, New Zealand

Christchurch Women's Hospital, Christchurch, New Zealand

Kidz First, Middlemore Hospital, Otahuhu, Auckland, New Zealand

Department of Paediatrics and Child Health, The Canberra Hospital, Garran, Australian Capital Territory 2605, Australia

Neonatalogy John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia

University of Queensland, Royal Children's Hospital, Herston, Queensland 4029, Australia

Peninsula Clinical Research Centre, Kippa-Ring, Queensland 4021, Australia

Caboolture Clinical Research, Caboolture, Queensland 4510, Australia

Hospital Clinico de la Universidad de Chile, Independencia, Santiago, Chile

Hospital San Jose, Independencia, Santiago, Chile

Women's and Children's Hospital, North Adelaide, South Australia 5006, Australia

Respiratory Medicine Department, Royal Children's Hospital, Parkville, Victoria 3052, Australia

Starting date: April 2006
Ending date: February 2007
Last updated: July 17, 2007