A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524 After Dosing for a Second Season in Children - Full Text View

Sponsor:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00113490

Purpose

The primary objective of this study is to determine the effect on immune reactivity to MEDI-524.

Condition	Intervention	Phase
Healthy	Biological: MEDI-524	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

Resource links provided by NLM:

Drug Information available for: Palivizumab MEDI-524

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Immunogenicity of MEDI-524 [ Time Frame: · Serum ELISA binding activity at each data collection visit will be summarized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of MEDI-524 and palivizumab as measured by [ Time Frame: through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug ] [ Designated as safety issue: Yes ]
Pharmacokinetics of MEDI-524 [ Time Frame: · Serum concentrations at each data collection visit will be summarized ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2006
Study Completion Date:	June 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients will receive 15 mg/kg MEDI-524 or palivizumab administered IM every 30 days for a total of 4-5 injections.	Biological: MEDI-524 Patients will receive 15 mg/kg MEDI-524 or palivizumab administered IM every 30 days for a total of 4-5 injections.

Detailed Description:

The primary objective of this study is to determine the effect on immune reactivity to MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 administered for a second season, in children who previously received MEDI-524 in protocol MI-CP104. The secondary objectives are to 1) describe the safety and tolerability of MEDI-524 administered for a second season; 2) describe the serum concentration of MEDI-524 administered for a second season.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion Criteria:

Be hospitalized
Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
Evidence of infection with hepatitis A, B, or C virus
Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
Acute illness or progressive clinical disorder
Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
Previous reaction to IGIV, blood products, or other foreign proteins
Have ever received palivizumab
Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
Currently participating in any investigational study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113490

Locations

Brazil
Hospital Das Clinicas Da Faculdade
Ribeirao Preto, Brazil, 14049-900
Pontificia Universidade Catolica Do Rio Grande
Porto Alegre, Brazil, 90610-000
Chile
Hospital Clinico De La Pointificia Universidad
Santiago, Chile
Hospital Dr. Sotero Del Rio
Santiago, Chile
Hospital San Jose
Santiago, Chile
Hospital Clinico de la Universidad de Chile
Santiago, Chile

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Pam Lupien, M.D.

MedImmune LLC

More Information

No publications provided

Responsible Party:	MedImmune Inc. ( Pam Lupien, M.D. )
Study ID Numbers:	MI-CP118
Study First Received:	June 8, 2005
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00113490 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Received at least 3 injections of MEDI-524

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Palivizumab
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010