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Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

NCT01006629 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-07-19

Study results available
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Summary

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

Conditions

  • Respiratory Syncytial Virus Infection
  • Premature Birth
  • Bronchopulmonary Dysplasia
  • Congenital Heart Disease

Interventions

BIOLOGICAL

palivizumab

palivizumab 15 mg/kg intramuscularly

Sponsors & Collaborators

Principal Investigators

  • Konstantin M Gudkov, MD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-07-31

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006629 on ClinicalTrials.gov