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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00316654
First received: April 19, 2006
Last updated: July 21, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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)
  Eligibility

Ages Eligible for Study:   7 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 Vaccines
GlaxoSmithKline
Investigators
Principal Investigator: Novartis Vaccines Drug Information Services Novartis Vaccines & Diagnostics
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov 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
immunology
child
antibody persistence

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

ClinicalTrials.gov processed this record on July 27, 2017