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

Condition(s) targeted: Healthy

Intervention: MEDI-524 (Biological)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: MedImmune LLC

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

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study

Primary outcome: Immunogenicity of MEDI-524

Secondary outcome:

Safety and tolerability of MEDI-524 and palivizumab as measured by

Pharmacokinetics of MEDI-524

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.

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

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

Hospital Das Clinicas Da Faculdade, Ribeirao Preto 14049-900, Brazil

Pontificia Universidade Catolica Do Rio Grande, Porto Alegre 90610-000, Brazil

Hospital Clinico De La Pointificia Universidad, Santiago, Chile

Hospital Clinico de la Universidad de Chile, Santiago, Chile

Hospital San Jose, Santiago, Chile

Hospital Dr. Sotero Del Rio, Santiago, Chile

Starting date: October 2006
Ending date: June 2007
Last updated: December 27, 2007