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

Tracking Information

First Received Date ^ICMJE

April 3, 2006

Last Updated Date

March 12, 2007

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00310713 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Prevention of Meningococcal Infection

Intervention ^ICMJE

Biological: Meningococcal C conjugate vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy children

Exclusion Criteria:

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

Gender

Both

Ages

12 Months and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00310713

Responsible Party

Study ID Numbers ^ICMJE

M14P5E1, Impact N° 1637

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Principal Investigator:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

Information Provided By

Novartis

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP