Clinical Trial: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

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

Official Title: A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant V

Brief Summary: This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • Percentage of Subjects With hSBA Titer >=1:8 - US Subjects [ Time Frame: 13 months of age (one month post-toddler vaccination) ]
    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
  • Geometric Mean hSBA Titers - US Subjects [ Time Frame: 13 months of age (one month post-toddler vaccination) ]
    Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.


Original Primary Outcome: Immunogenicity of routine infant vaccines when given concomitantly with MenACWY in a primary vaccine series and as a booster at 12 months of age as measured by serum bactericidal antibodies.

Current Secondary Outcome:

  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series [ Time Frame: 7 days post vaccination ]
    Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series [ Time Frame: 7 days post vaccination ]
    Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series [ Time Frame: 7 days post-vaccination ]
    Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series [ Time Frame: 7 days post-vaccination ]
    Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
  • Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series [ Time Frame: 7 days post-vaccination ]
    Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
  • Geometric Mean hSBA Titers Post-infant Series - US Subjects [ Time Frame: 7 months of age (one month post-infant series) ]
    Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
  • Geometric Mean hSBA Titers Post-infant Series - LA Subjects [ Time Frame: 7 months of age (one month post-infant series) ]
    Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
  • Percentage of Subjects With hSBA Titer >=1:8 - US Subjects [ Time Frame: 7 months of age (one month post-infant series) ]
    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
  • Percentage of Subjects With hSBA Titer >=1:4 - US Subjects [ Time Frame: 7 months of age (one month post-infant series) ]
    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
  • Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects [ Time Frame: 7 months of age (one month post-infant series) ]
    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
  • Percentage o

    Original Secondary Outcome:

    • Immunogenicity of Novertis MenACWY Conjugate Vaccine when given in an alternative primary or boost schedule
    • Safety and tolerability of Novartis MenACWY when given with concomitant vaccines during routine primary series or booster doses


    Information By: Novartis

    Dates:
    Date Received: May 16, 2007
    Date Started: March 2007
    Date Completion:
    Last Updated: February 24, 2014
    Last Verified: February 2014