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Persistence of Immune Response After Vaccination With MCC

This study has been completed.
Novartis Vaccines
Information provided by:
Novartis Identifier:
First received: April 3, 2006
Last updated: September 18, 2014
Last verified: September 2014
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)

Ages Eligible for Study:   11 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00310687

United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Headington, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Novartis Vaccines
Principal Investigator: Vaccines - Information Services Novartis Vaccines & Diagnostics
  More Information Identifier: NCT00310687     History of Changes
Other Study ID Numbers: M14P2E1
Impact N° 919
Study First Received: April 3, 2006
Last Updated: September 18, 2014

Keywords provided by Novartis:
Prevention of Meningococcal Meningitis
antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections processed this record on September 21, 2017