NCT00192478

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2004

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 28, 2008

Status Verified

July 1, 2008

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

July 24, 2008

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

  • Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease

    30 days after patient's final dose of study drug

  • Pharmacokinetics of MEDI-524

    · Serum concentrations at each data collection visit will be summarized

Secondary Outcomes (1)

  • Immunogenicity of MEDI-524

    · Serum ELISA binding activity at each data collection visit will be summarized

Study Arms (1)

1

ACTIVE COMPARATOR

MEDI-524

Biological: Medi-524

Interventions

Medi-524BIOLOGICAL

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

1

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital General de Niños "Ricardo Gutierrez"

Buenos Aires, 1330, Argentina

Location

Hospital Interzonal General de Agudos "Dr. Diego Paroissien

Buenos Aires, 5975, Argentina

Location

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

motavizumab

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Genevieve Losonsky, MD

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

February 1, 2004

Primary Completion

May 1, 2006

Study Completion

August 1, 2006

Last Updated

July 28, 2008

Record last verified: 2008-07

Locations

AR(2)CL(1)