Clinical Trial: Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single D

Brief Summary: This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. [ Time Frame: One month after vaccinations ]
    Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
  • Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. [ Time Frame: One month after vaccinations ]

    Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:

    • prior to the first vaccination
    • 30 days following the first, second, prior to the third and 30 days after the third vaccination
  • Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. [ Time Frame: One month after vaccinations ]
    Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
  • Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vacc

    Original Primary Outcome:

    • 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 ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    • 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 ]


    Information By: Novartis

    Dates:
    Date Received: November 16, 2007
    Date Started: July 2007
    Date Completion:
    Last Updated: March 3, 2016
    Last Verified: March 2016