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Trial record 2 of 2 for:    "Nephrotic Syndrome, Type 2" | "Cyclosporins"

Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

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ClinicalTrials.gov Identifier: NCT01346007
Recruitment Status : Unknown
Verified January 2009 by National and Kapodistrian University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE April 29, 2011
First Posted Date  ICMJE May 2, 2011
Last Update Posted Date May 2, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Pneumococcal serotype-specific antibodies and B memory cells [ Time Frame: Within the first 30 days after vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Incidence of relapses of idiopathic nephrotic syndrome [ Time Frame: Within 12 months after vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Official Title  ICMJE Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
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.
Detailed Description

Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in children under 16 years old with incidence rate 2-7/100,000 patients/year depending on ethnicity. Those patients are susceptible to invasive pneumococcal disease (IPD) including peritonitis, pneumonia with or without pleural effusion and meningitis. Due to increased mortality and risk of relapses associated with IPD, it has been recommended that children with INS should be immunized with pneumococcal conjugate vaccine [1]. However, concerns on vaccine safety and impaired immunogenicity due to INS pathogenesis and immunosuppressive treatment are a hurdle for universal implementation of existing guidelines.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Idiopathic Nephrotic Syndrome
Intervention  ICMJE Biological: 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 Name: Prevenar; Wyeth Vaccines
Study Arms  ICMJE
  • Active Comparator: patients
    Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
  • Active Comparator: controls
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 29, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female
  • Between 2-20 years of age

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346007
Other Study ID Numbers  ICMJE NKU 7049687
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Vana Spoulou, 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National and Kapodistrian University of Athens
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP