Text Size

Kinetics of B Cell Response in Infants Menjugate Vaccination

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00310700
First received: April 3, 2006
Last updated: March 12, 2007
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   8 Weeks to 11 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00310700     History of Changes
Other Study ID Numbers: M14P5, Impact N° 1457
Study First Received: April 3, 2006
Last Updated: March 12, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 21, 2013