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Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

Primary Purpose

Prevention of Meningococcal Infection

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Meningococcal C conjugate vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Meningococcal Infection focused on measuring Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, children, antibody persistence

Eligibility Criteria

12 Months - 13 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy children Exclusion Criteria: Known hypersensitivity to any vaccine products Any immunodeficiency, genetic anomaly or severe acute or chronic illness

Sites / Locations

  • Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Outcomes

Primary Outcome Measures

Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution

Secondary Outcome Measures

Immune Response measured 4 weeks after the booster immunisation.
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

Full Information

First Posted
April 3, 2006
Last Updated
September 18, 2014
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00310713
Brief Title
Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine
Official Title
A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the C Saccharide Component of Chiron's Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine 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
April 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine

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, children, 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
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Arm Title
Group 4
Arm Type
Experimental
Arm Title
Group 5
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Meningococcal C conjugate vaccine
Intervention Description
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Primary Outcome Measure Information:
Title
Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution
Secondary Outcome Measure Information:
Title
Immune Response measured 4 weeks after the booster immunisation.
Title
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children Exclusion Criteria: Known hypersensitivity to any vaccine products Any immunodeficiency, genetic anomaly or severe acute or chronic illness
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
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18250423
Citation
Blanchard Rohner G, Snape MD, Kelly DF, John T, Morant A, Yu LM, Borkowski A, Ceddia F, Borrow R, Siegrist CA, Pollard AJ. The magnitude of the antibody and memory B cell responses during priming with a protein-polysaccharide conjugate vaccine in human infants is associated with the persistence of antibody and the intensity of booster response. J Immunol. 2008 Feb 15;180(4):2165-73. doi: 10.4049/jimmunol.180.4.2165. Erratum In: J Immunol. 2011 May 15;186(10):6064.
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Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

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