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Persistence of Immune Response After Vaccination With MCC

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310687
First Posted: April 4, 2006
Last Update Posted: September 19, 2014
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.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  Purpose
Persistence of Immune response after vaccination with MCC

Condition Intervention Phase
Prevention of Meningococcal Infection Procedure: BLOOD DRAW Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Estimated Enrollment: 1244
Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310687


Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Headington, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Principal Investigator: Vaccines - Information Services Novartis Vaccines & Diagnostics
  More Information

ClinicalTrials.gov Identifier: NCT00310687     History of Changes
Other Study ID Numbers: M14P2E1
Impact N° 919
First Submitted: April 3, 2006
First Posted: April 4, 2006
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Novartis:
Prevention of Meningococcal Meningitis
vaccines
conjugate
immunology
antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections