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

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

U.S. FDA Resources

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

Ages Eligible for Study:	12 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy children

Exclusion Criteria:

Known hypersensitivity to any vaccine products
Any immunodeficiency, genetic anomaly or severe acute or chronic illness

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

Study ID Numbers:	M14P5E1, Impact N° 1637
First Received:	April 3, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00310713
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

Healthy

Meningococcal infection

Gram-Negative Bacterial Infections

Neisseriaceae Infections

Meningitis

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 05, 2008

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