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Persistence of Antibody Response to N. Meningitidis Group C in Children

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00316654
First received: April 19, 2006
Last updated: September 13, 2006
Last verified: September 2006
History of Changes
  Purpose

Persistence of Antibody Response to N. meningitidis Group C in Children


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV, Multi-Center, Open-Label, Unrandomized Study to Evaluate the Persistence of Antibody Response to N. Meningitidis Group C, Before and After 2 Doses of the Conjugate Pneumococcal Vaccine, in Children Seven Months and Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine and a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary Outcome Measures:
  • Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
  • safety and tolerability

Estimated Enrollment: 573
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   7 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy children

Exclusion Criteria:

  • previous ascertained or suspected disease caused by N. meningitidis
  • previous significant acute or chronic infections
  • any other serious disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316654

Locations
Poland
Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland
Spain
Valencia, Spain
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Principal Investigator: Novartis Vaccines - Drug Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316654     History of Changes
Other Study ID Numbers: V14P38E1, Impact N° 1396
Study First Received: April 19, 2006
Last Updated: September 13, 2006
Health Authority: Spain: Spanish Agency of Medicines
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013