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

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

February 28, 2007

Study Completion Date

February 28, 2007

Conditions
Respiratory Syncytial Virus InfectionsChronic Lung Disease and <= 24 Months of Age orPremature With Gestational Age <=35 Weeks and <=6 Months of Age
Interventions
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.

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.

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.

Trial Locations (19)

2305

Neonatalogy John Hunter Hospital, New Lambton Heights

2605

Department of Paediatrics and Child Health, The Canberra Hospital, Garran

3052

Respiratory Medicine Department, Royal Children's Hospital, Parkville

4021

Peninsula Clinical Research Centre, Kippa-Ring

4029

University of Queensland, Royal Children's Hospital, Herston

4510

Caboolture Clinical Research, Caboolture

5006

Women's and Children's Hospital, North Adelaide

Unknown

Hospital Clinico de la Universidad de Chile, Independencia

Hospital San Jose, Independencia

Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago

Hospital Clinico San Borja Arriaran, Santiago

Hospital Dr Felix Bulnes Cerda, Santiago

Hospital Dr. Sotero del Rio, Santiago

Hospital Padre Hurtado, Santiago

Kidz First, Middlemore Hospital, Otahuhu

Christchurch Women's Hospital, Christchurch

Paediatric Medicine, Dunedin Hospital, Dunedin

Department of Paediatrics, Waikato Hospital, Hamilton

Child Health, Palmerston North Hospital, Palmerston North

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY