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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: September 18, 2014
Last verified: September 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
ClinicalTrials.gov Identifier: NCT00310700     History of Changes
Other Study ID Numbers: M14P5, Impact N° 1457, 2004-004962-33
Study First Received: April 3, 2006
Last Updated: September 18, 2014
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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 20, 2014