Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

NCT ID: NCT00192478

Last Updated: 2008-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-08-31

Brief Summary

MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.

Detailed Description

This study is designed to describe the safety, tolerability, immunogenicity, and pharmacokinetics of escalating, repeated IM injections (the intended route of administration for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of infants at high risk for serious RSV disease.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

MEDI-524

Group Type: ACTIVE_COMPARATOR

Medi-524

Intervention Type: BIOLOGICAL

IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals

Interventions

Medi-524

IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• All male or female children must have met all the following criteria:
• [Groups 1, 2, and 3] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or [Group 3 only] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months
• The child must have been in general good health at the time of entry
• The child's parent or legal guardian must have provided written informed consent; and
• The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524
• Parent/legal guardian of patient must have had available telephone access

Exclusion Criteria

• Children must have had none of the following:
• Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study)
• [All children in Groups 1 and 2; only children £6 months of age in Group 3] Birth hospitalization >6 weeks duration or [Only children >6 months of age in Group 3] Birth hospitalization >12 weeks duration
• Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP)
• [Groups 1 and 2 only] Diagnosis of BPD, defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days
• 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
• Mother with known HIV infection
• Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age; AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age; hemoglobin <9.5 gm/dL; white blood cell count <4,000 cells/mm3; platelet count <120,000 cells/mm3
• Acute illness or progressive clinical disorder
• Active infection, including acute RSV infection
• 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 [RespiGamÒ], IVIG), or any investigational agents
• Currently participating in any investigational study
• Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Genevieve Losonsky, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Hospital General de Niños "Ricardo Gutierrez"

Buenos Aires, , Argentina

Hospital Interzonal General de Agudos "Dr. Diego Paroissien

Buenos Aires, , Argentina

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, , Chile

Countries

Argentina; Chile

Other Identifiers

MI-CP104

Identifier Type: -

Identifier Source: org_study_id