Back to resultsPersistence of Immune Response After Vaccination With MCC
Primary Purpose
Prevention of Meningococcal Infection
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
BLOOD DRAW
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, antibody persistence
Eligibility Criteria
Inclusion Criteria: healthy adolescents vaccinated with Meningococcal C Conjugate vaccine Exclusion Criteria: ascertained or suspected disease caused by N. meningitidis household contact with individuals with proven N. meningitidis serogroup C infection significant acute or chronic infections any other serious disease
Sites / Locations
- Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Outcomes
Primary Outcome Measures
persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
Secondary Outcome Measures
Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C
Full Information
NCT ID
NCT00310687
First Posted
April 3, 2006
Last Updated
September 18, 2014
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00310687
Brief Title
Persistence of Immune Response After Vaccination With MCC
Official Title
A Phase IV, Single Centre, Open-label Study to Evaluate the Persistence of Antibodies in Adolescents 14-16 Years of Age, Vaccinated With Chiron Meningococcal C Conjugate Vaccine During the 1999-2001 UK MenCC Immunization Campaign, at One Year After Either a Challenge Dose of Aventis Pasteur MSD Meningococcal A/C Polysaccharide Vaccine or a Booster Dose of MenC Vaccine, in Parallel to Subjects Aged 11-20 Evaluated at 4 Years After Vaccination During the 1999-2001 UK MenCC Immunization Campaign
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
Persistence of Immune response after vaccination with MCC
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, 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
1244 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
BLOOD DRAW
Primary Outcome Measure Information:
Title
persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
Secondary Outcome Measure Information:
Title
Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
Title
Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy adolescents vaccinated with Meningococcal C Conjugate vaccine
Exclusion Criteria:
ascertained or suspected disease caused by N. meningitidis
household contact with individuals with proven N. meningitidis serogroup C infection
significant acute or chronic infections
any other serious disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Headington
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
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Persistence of Immune Response After Vaccination With MCC
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