Back to resultsKinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
Primary Purpose
Meningococcal Disease; Meningococcal Meningitis
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
· Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Disease; Meningococcal Meningitis
Eligibility Criteria
Inclusion Criteria: Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided. Exclusion Criteria: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
Sites / Locations
- University of Oxford, The Oxford Vaccine Group
Outcomes
Primary Outcome Measures
To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
Secondary Outcome Measures
To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00262015
Brief Title
Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
Official Title
A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chiron Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease; Meningococcal Meningitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
· Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)
Primary Outcome Measure Information:
Title
To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
Secondary Outcome Measure Information:
Title
To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Eligibility Criteria
Inclusion Criteria:
Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided.
Exclusion Criteria:
Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J. Pollard, MBBS, FRCPCH, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oxford, The Oxford Vaccine Group
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
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