Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine safely induces immune responses and immunological memory in children with idiopathic nephrotic syndrome in remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 29, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 2, 2011
January 1, 2009
1.4 years
April 29, 2011
April 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Pneumococcal serotype-specific antibodies and B memory cells
Within the first 30 days after vaccination
Secondary Outcomes (1)
Incidence of relapses of idiopathic nephrotic syndrome
Within 12 months after vaccination
Study Arms (2)
patients
ACTIVE COMPARATORChildren with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
controls
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Male or Female
- Between 2-20 years of age
You may not qualify if:
- serious allergic reaction to previous vaccination
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Goudi, Athens, 11527, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Theodoridou, Dr
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
- STUDY DIRECTOR
Vana Spoulou, Dr
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
- PRINCIPAL INVESTIGATOR
Christina Liakou, MD
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 2, 2011
Study Start
January 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2011
Last Updated
May 2, 2011
Record last verified: 2009-01