Kinetics of B Cell Response in Infants Menjugate Vaccination

Phase 4

Completed

• Conditions: Prevention of Meningococcal Infection

• Registration Number: NCT00310700
• Lead Sponsor: Novartis

Brief Summary

Kinetics of B cell response in infants Menjugate vaccination

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• healthy infants

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
To establish how long the B cells persist in the blood

Trial Locations

Locations (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital; 🇬🇧 Oxford, Oxon, United Kingdom