Kinetics of B Cell Response in Infants Menjugate Vaccination

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:	NCT00310700

Purpose

Kinetics of B cell response in infants Menjugate vaccination

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 First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.

Secondary Outcome Measures:

To establish how long the B cells persist in the blood
To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation

Estimated Enrollment:	75
Study Start Date:	May 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

previously ascertained or suspected disease caused by N. meningitidis
previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310700

Locations

United Kingdom, OXON
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, OXON, 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:	M14P5, Impact N° 1457
Study First Received:	April 3, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00310700 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
vaccines, conjugate
immunology
infant
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