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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 is currently recruiting participants.
Verified by Novartis, November 2007
First Received: November 16, 2007   No Changes Posted
Sponsors and Collaborators: Novartis
Novartis Vaccines
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00560313
  Purpose

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


Condition Intervention Phase
Meningococcal Disease
Biological: serogroups ACWY meningococcal vaccine
Biological: Serogroup B meningococcal Vaccine
Phase II

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: July 2007
Estimated Study Completion Date: April 2009
Arms Assigned Interventions
1 Biological: serogroups ACWY meningococcal vaccine
a single dose of a 0.5 mL injectable solution
Biological: Serogroup B meningococcal Vaccine
All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560313

Contacts
Contact: Novartis Drug information services +1 800 244 7668

Locations
Italy
Azienda USL 7 of Siena Recruiting
Siena, Italy, 53100
Contact     0039 0577 51293        
Principal Investigator: Novartis Vaccines            
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Study ID Numbers: V72P4, 2007-001563-29
Study First Received: November 16, 2007
Last Updated: November 16, 2007
ClinicalTrials.gov Identifier: NCT00560313     History of Changes
Health Authority: Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:
Meningococcal disease
prevention
vaccination

Study placed in the following topic categories:
Bacterial Infections
Meningococcal Infections
Healthy
Meningococcal Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

Additional relevant MeSH terms:
Bacterial Infections
Meningococcal Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on July 02, 2009