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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: April 19, 2006
Last updated: July 21, 2017
Last verified: July 2017
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
Intervention Model: Parallel Assignment
Masking: None (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 & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Vaccines ):

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

Enrollment: 489
Study Start Date: February 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   7 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00316654

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

Responsible Party: Novartis Vaccines Identifier: NCT00316654     History of Changes
Other Study ID Numbers: V14P38E1
2004-001522-24 ( EudraCT Number )
Study First Received: April 19, 2006
Last Updated: July 21, 2017

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

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on August 17, 2017