Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
NCT ID: NCT01346007
Last Updated: 2011-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2009-01-31
2011-06-30
Brief Summary
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Detailed Description
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To thoroughly evaluate safety of 7-valent pneumococcal conjugate vaccine (PCV7) in children with INS in remission, we will investigate a possible association of vaccination with increased risk for recurrences of INS. We will also study immunogenicity and kinetics of immune response in INS patients and healthy subjects and the effect of different types of treatment on primary immune response and antibody persistence at 12-14 months following vaccination with PCV7.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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patients
Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
7-valent pneumococcal conjugate vaccine
A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming
controls
7-valent pneumococcal conjugate vaccine
A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming
Interventions
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7-valent pneumococcal conjugate vaccine
A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 2-20 years of age
Exclusion Criteria
* history of invasive pneumococcal disease
* vaccination with pneumococcal conjugate vaccine
* vaccination with pneumococcal polysaccharide vaccine
* administration of intravenous immunoglobulin or other blood products during the last 3 months
2 Years
20 Years
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Principal Investigators
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Maria Theodoridou, Dr
Role: STUDY_CHAIR
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Vana Spoulou, Dr
Role: STUDY_DIRECTOR
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Christina Liakou, MD
Role: PRINCIPAL_INVESTIGATOR
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Locations
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1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Goudi, Athens, Greece
Countries
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Other Identifiers
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NKU 7049687
Identifier Type: -
Identifier Source: org_study_id
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