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Kinetics of B Cell Response in Infants Menjugate Vaccination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310700
First Posted: April 4, 2006
Last Update Posted: September 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  Purpose
Kinetics of B cell response in infants Menjugate vaccination

Condition Intervention Phase
Prevention of Meningococcal Infection Biological: Meningococcal C conjugate vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Weeks to 11 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310700


Locations
United Kingdom
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

Publications:
ClinicalTrials.gov Identifier: NCT00310700     History of Changes
Other Study ID Numbers: M14P5
Impact N° 1457
2004-004962-33 ( EudraCT Number )
First Submitted: April 3, 2006
First Posted: April 4, 2006
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Novartis:
Prevention of Meningococcal Meningitis
vaccines, conjugate
immunology
infant
antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs