Clinical Trial: Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

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

Official Title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75 Years of Age in India.

Brief Summary: This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome:

  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. [ Time Frame: Day 29 (1 month post vaccination) ]
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A.
  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C [ Time Frame: Day 29 (1 month post vaccination) ]
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. [ Time Frame: Day 29 (1 month post vaccination) ]
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. [ Time Frame: Day 29 (1 month post vaccination) ]
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.


Original Primary Outcome: Immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y. [ Time Frame: 29 days ]

Current Secondary Outcome:

  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. [ Time Frame: Day 29 (ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. [ Time Frame: Day 29 (ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. [ Time Frame: Day 29 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.
  • Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 [ Time Frame: Day 29 (ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.
  • hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.
  • hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 [ Time Frame: Day 29 ( ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.
  • hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.
  • hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 [ Time Frame: Day 29 (ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.
  • hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 [ Time Frame: Day 1 ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.
  • hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 [ Time Frame: Day 29 (ie, 1 month post vaccination) ]
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.
  • hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 [ Time Frame: Day 1 

    Original Secondary Outcome:

    • Immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y. [ Time Frame: 29 days ]
    • Safety profile following MenACWY-CRM vaccination in terms of percentage and number of subjects with: [ Time Frame: 29 Days ]
      • Local and systemic reactions reported from day 1 (day of vaccination) through day 7 post vaccination.
      • All other adverse events (AEs) reported from day 1 through day 7 postvaccination.
      • Serious adverse events (SAEs) and medically attended AEs from day 1 through day 29


    Information By: Novartis

    Dates:
    Date Received: February 23, 2012
    Date Started: March 2012
    Date Completion:
    Last Updated: December 18, 2014
    Last Verified: December 2014