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Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
This study has been completed.
Study NCT00560313   Information provided by Novartis
First Received: November 16, 2007   Last Updated: November 16, 2009   History of Changes

November 16, 2007
November 16, 2009
July 2007
 
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after completion of immunization schedule [ Time Frame: one month ]
  • Safety and tolerability of the two Meningococcal vaccines throughout the clinical study [ Time Frame: one month ]
Same as current
Complete list of historical versions of study NCT00560313 on ClinicalTrials.gov Archive Site
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after the first and the second immunization [ Time Frame: one month ]
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal ACWY vaccine at one month after the immunization [ Time Frame: one month ]
Same as current
 
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Vaccine in Healthy At-risk Adults 18-50 Years of Age

This study is aimed to evaluate safety, tolerabilty and immunogenicity of three doses of Novartis Meningococcal B vaccine and of one dose of Novartis Menongococcal ACWY vaccine when adnministered to healthy at-risk adults

 
Phase II
Interventional
Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Meningococcal Disease
  • Biological: serogroups ACWY meningococcal vaccine
  • Biological: Serogroup B meningococcal Vaccine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
250
November 2009
 

Inclusion Criteria:

  • healthy adults,18 through 50 years of age, who are or may be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

  • previous ascertained or suspected disease caused by N. meningitidis;
  • pregnancy or breastfeeding;
  • history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
  • any present or suspected serious acute or chronic disease
  • known or suspected autoimmune disease or impairment /alteration of immune function
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00560313
 
V72P4, 2007-001563-29
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
November 2009

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