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
  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:


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
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: 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 August 25, 2014