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: September 18, 2014
Last verified: September 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 18, 2014
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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 23, 2014