Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

This study has been completed.

First Received: April 3, 2006 Last Updated: March 12, 2007 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310713

Purpose

Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine

Condition	Intervention	Phase
Prevention of Meningococcal Infection	Biological: Meningococcal C conjugate vaccine	Phase IV

MedlinePlus related topics: Childhood Immunization

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase IV, Single Centre, Open-Label Study to Investigate the Kinetics of the B Cell Response to the C Saccharide Component of Chiron’s Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine at 2, 3 and 4 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution

Secondary Outcome Measures:

Immune Response measured 4 weeks after the booster immunisation.
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

Estimated Enrollment:	72
Study Start Date:	April 2006

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310713

Locations

United Kingdom, Oxford
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Headington, Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M14P5E1, Impact N° 1637
Study First Received:	April 3, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00310713 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
vaccines
conjugate

immunology
children
antibody persistence

Study placed in the following topic categories:

Bacterial Infections
Antibodies
Meningococcal Infections
Meningitis, Meningococcal
Meningococcal Infection

Healthy
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