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Persistence of Immune Response After Vaccination With MCC

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00310687
First received: April 3, 2006
Last updated: March 7, 2007
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   11 Years to 20 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00310687     History of Changes
Other Study ID Numbers: M14P2E1, Impact N° 919
Study First Received: April 3, 2006
Last Updated: March 7, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 21, 2013