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

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ClinicalTrials.gov Identifier: NCT00310713
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine

Condition or disease Intervention/treatment Phase
Prevention of Meningococcal Infection Biological: Meningococcal C conjugate vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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 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
Study Start Date : April 2006
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1 Biological: Meningococcal C conjugate vaccine
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Experimental: Group 2 Biological: Meningococcal C conjugate vaccine
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Experimental: Group 3 Biological: Meningococcal C conjugate vaccine
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Experimental: Group 4 Biological: Meningococcal C conjugate vaccine
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Experimental: Group 5 Biological: Meningococcal C conjugate vaccine
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)


Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Immune Response measured 4 weeks after the booster immunisation.
  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Known hypersensitivity to any vaccine products
  • Any immunodeficiency, genetic anomaly or severe acute or chronic illness
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): NCT00310713


Locations
United Kingdom
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Headington, Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
Investigators
Principal Investigator: Novartis Vaccines - Information Services Novartis Vaccines & Diagnostics
More Information

Publications:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00310713     History of Changes
Other Study ID Numbers: M14P5E1
Impact N° 1637
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Novartis ( Novartis Vaccines ):
Prevention of Meningococcal Meningitis
vaccines
conjugate
immunology
children
antibody persistence

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