Back to resultsKinetics of B Cell Response in Infants Menjugate Vaccination
Primary Purpose
Prevention of Meningococcal Infection
Status
Completed
Phase
Phase 4
Locations
United Kingdom
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, infant, antibody persistence
Eligibility Criteria
Inclusion Criteria: healthy infants Exclusion Criteria: previously ascertained or suspected disease caused by N. meningitidis previous household contact with an individual with a positive culture of N. meningitidis serogroup C
Sites / Locations
- Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Outcomes
Primary Outcome Measures
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
Secondary Outcome Measures
To establish how long the B cells persist in the blood
To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
Full Information
NCT ID
NCT00310700
First Posted
April 3, 2006
Last Updated
September 18, 2014
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00310700
Brief Title
Kinetics of B Cell Response in Infants Menjugate Vaccination
Official Title
A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
Kinetics of B cell response in infants Menjugate vaccination
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, infant, antibody persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Meningococcal C conjugate vaccine
Primary Outcome Measure Information:
Title
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
Secondary Outcome Measure Information:
Title
To establish how long the B cells persist in the blood
Title
To note the difference between plasma cell response following the first and third MenC vaccination.
Title
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy infants
Exclusion Criteria:
previously ascertained or suspected disease caused by N. meningitidis
previous household contact with an individual with a positive culture of N. meningitidis serogroup C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19175802
Citation
Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x. Erratum In: Immunology. 2011 Apr;132(4):589.
Results Reference
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Kinetics of B Cell Response in Infants Menjugate Vaccination
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