Back to resultsPersistence of Antibody Response to N. Meningitidis Group C in Children
Primary Purpose
Prevention of Meningococcal Infection
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Meningococcal C conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Meningococcal Infection focused on measuring Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, child, antibody persistence
Eligibility Criteria
Inclusion Criteria: healthy children Exclusion Criteria: previous ascertained or suspected disease caused by N. meningitidis previous significant acute or chronic infections any other serious disease
Sites / Locations
Outcomes
Primary Outcome Measures
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Secondary Outcome Measures
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability
Full Information
NCT ID
NCT00316654
First Posted
April 19, 2006
Last Updated
July 21, 2017
Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00316654
Brief Title
Persistence of Antibody Response to N. Meningitidis Group C in Children
Official Title
A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Persistence of Antibody Response to N. meningitidis Group C in Children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Meningococcal Infection
Keywords
Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, child, antibody persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
489 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Meningococcal C conjugate vaccine
Primary Outcome Measure Information:
Title
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Secondary Outcome Measure Information:
Title
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
Title
safety and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy children
Exclusion Criteria:
previous ascertained or suspected disease caused by N. meningitidis
previous significant acute or chronic infections
any other serious disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Principal Investigator
Facility Information:
City
Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz
Country
Poland
City
Valencia
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Persistence of Antibody Response to N. Meningitidis Group C in Children
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