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

Sponsor:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00316264

Purpose

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).

Condition	Intervention	Phase
Respiratory Syncytial Virus Infections Chronic Lung Disease	Drug: MEDI-524	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Syncytial Virus Infections

Drug Information available for: Palivizumab MEDI-524

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

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. [ Time Frame: May 14, 2007 ]

Secondary Outcome Measures:

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. [ Time Frame: May 14, 2007 ]

Enrollment:	260
Study Start Date:	April 2006
Study Completion Date:	April 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316264

Locations

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

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Pamela Griffin, M.D.

MedImmune LLC

More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fernández 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.

ClinicalTrials.gov Identifier:	NCT00316264 History of Changes
Other Study ID Numbers:	MI-CP127
Study First Received:	April 18, 2006
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Respiratory Syncytial Virus
Premature and under 6 mos. of age
Chronic Lung Disease over 6 mos. of age

Additional relevant MeSH terms:

Lung Diseases
Respiratory Syncytial Virus Infections
Virus Diseases
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections

RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012