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

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ClinicalTrials.gov Identifier: NCT00316654
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Persistence of Antibody Response to N. meningitidis Group C in Children

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 489 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00316654     History of Changes
Other Study ID Numbers: V14P38E1
2004-001522-24 ( EudraCT Number )
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 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