Clinical Trial: Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

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

Official Title: A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococ

Brief Summary: This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination [ Time Frame: One Month After Last Vaccination ( day 86) ]

    Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart.

    Seroresponse is defined as:

    1. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4;
    2. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
  • Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination [ Time Frame: One Month After Last Vaccination (day 86) ]
    Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination

    Original Primary Outcome: Percentage of subjects with hSBA seroresponse [ Time Frame: Day 29 post dose 2 ]

    1. To demonstrate non inferiority of two doses (given 2 months apart) versus one dose of MenACWY-CRM vaccine, by age group (2 to 5 years of age; 6 to 10 years of age), as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
    2. To demonstrate superiority of two doses (given 2 months apart) versus one dose of MenACWY-CRM vaccine, by age group (2 to 5 years of age; 6 to 10 years of age), as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.


    Current Secondary Outcome:

    • Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM [ Time Frame: One Month After Last Vaccination (day 86) ]
      Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.
    • Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM [ Time Frame: One Month After Last Vaccination (day 86) ]
      Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.
    • Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM [ Time Frame: One year after one vaccination or two vaccinations (day 422). ]
      Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.
    • Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM [ Time Frame: One year after one vaccination or two vaccinations (day 422). ]
      Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.
    • Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [ Time Frame: From Days 1-7 after each vaccination ]
      Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
    • Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [ Time Frame: From Days 1-7 after each vaccination ]
      Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
    • Number of Subjects Who Reported Selected AEs After Any Vaccination [ Time Frame: Day 1 to Day 86 ]
      Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM
    • Number of Subjects Who Reported Selected AEs After Any Vaccination [ Time Frame: Day 1 to Day 422 ]
      Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM


    Original Secondary Outcome:

    • Percentage of subjects with hSBA ≥1:8 [ Time Frame: Day 365 post dose 2 ]
      To compare the immunogenicity of either 1 or 2 doses of MenACWY as measured by the percentage of subjects with hSBA > 1:8 and hSBA GMTs at 1 month and 12 months after last vaccination
    • hSBA GMTs [ Time Frame: Day 29 and Day 365 post dose 2 ]
      To compare the safety of either one or two doses of MenACWY-CRM vaccine (given 2 months apart), by age group (2 to 5 years of age; 6 to 10 years of age).
    • Solicited local and systemic reactions [ Time Frame: Days 1-7 postvaccination ]
    • Unsolicited Adverse Events [ Time Frame: Days 1-28 postvaccination ]
    • Medically attended Adverse Events [ Time Frame: Day 365 post dose 2 ]
    • Adverse Events leading to premature withdrawal [ Time Frame: Day 365 post dose 2 ]
    • Serious Adverse Events [ Time Frame: Day 365 post dose 2 ]


    Information By: Novartis

    Dates:
    Date Received: September 7, 2012
    Date Started: October 2012
    Date Completion:
    Last Updated: February 20, 2015
    Last Verified: February 2015