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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. Identifier: NCT00310687
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : September 19, 2014
Novartis Vaccines
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Brief Summary:
Persistence of Immune response after vaccination with MCC

Condition or disease Intervention/treatment Phase
Prevention of Meningococcal Infection Procedure: BLOOD DRAW Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1244 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
  2. Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C

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

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

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 identifier (NCT number): NCT00310687

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

Layout table for additonal information Identifier: NCT00310687     History of Changes
Other Study ID Numbers: M14P2E1
Impact N° 919
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Novartis:
Prevention of Meningococcal Meningitis
antibody persistence
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs