Persistence of Immune Response After Vaccination With MCC - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310687

Purpose

Persistence of Immune response after vaccination with MCC

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

MedlinePlus related topics: Childhood Immunization

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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

Criteria

Inclusion Criteria:

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, Oxfordshire
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

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

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
vaccines
conjugate
immunology
antibody persistence

Study placed in the following topic categories:

Bacterial Infections
Antibodies
Meningococcal Infections
Meningitis, Meningococcal
Meningococcal Infection

Immunoglobulins
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 07, 2009