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

April 19, 2006
September 13, 2006
February 2005
Not Provided
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
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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 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

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
573
Not Provided
Not Provided

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
Both
7 Months and older
Yes
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain
 
NCT00316654
V14P38E1, Impact N° 1396
Not Provided
Not Provided
Novartis
Novartis Vaccines
Principal Investigator: Novartis Vaccines - Drug Information Services Novartis Vaccines & Diagnostics
Novartis
September 2006

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