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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316654
First Posted: April 21, 2006
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
April 19, 2006
April 21, 2006
July 25, 2017
February 2005
October 2005   (Final data collection date for primary outcome measure)
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Not Provided
Complete list of historical versions of study NCT00316654 on ClinicalTrials.gov Archive Site
  • Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
  • safety and tolerability
Not Provided
Not Provided
Not Provided
 
Persistence of Antibody Response to N. Meningitidis Group C in Children
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
Persistence of Antibody Response to N. meningitidis Group C in Children
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Prevention of Meningococcal Infection
Biological: Meningococcal C conjugate vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
October 2005
October 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Months and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain
 
 
NCT00316654
V14P38E1
2004-001522-24 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
GlaxoSmithKline
Principal Investigator: Novartis Vaccines Drug Information Services Novartis Vaccines & Diagnostics
Novartis
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP