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Persistence of Immune Response After Vaccination With MCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310687
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : September 19, 2014
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE April 3, 2006
First Posted Date  ICMJE April 4, 2006
Last Update Posted Date September 19, 2014
Study Start Date  ICMJE October 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00310687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Persistence of Immune Response After Vaccination With MCC
Official Title  ICMJE 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
Brief Summary Persistence of Immune response after vaccination with MCC
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Meningococcal Infection
Intervention  ICMJE Procedure: BLOOD DRAW
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 13, 2006)
1244
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00310687
Other Study ID Numbers  ICMJE M14P2E1
Impact N° 919
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Novartis Vaccines
Investigators  ICMJE
Principal Investigator: Vaccines - Information Services Novartis Vaccines & Diagnostics
PRS Account Novartis
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP