Clinical Trial: Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

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

Official Title: A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine

Brief Summary: The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Percentage of Subjects With hSBA ≥1:8 [ Time Frame: At 40 and 60 months of age ]

Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.


Original Primary Outcome: Immunogenicity as measured by serum bactericidal activity at 40 months and 60 months of age [ Time Frame: 40 and 60 months ]

Current Secondary Outcome:

  • Percentage of Subjects With hSBA ≥1:4 [ Time Frame: At 40 and 60 months of age ]
    Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
  • GMTs in Subjects Within Each Site and in Age-Matched Control Subjects [ Time Frame: At 40 and 60 months of age ]
    The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.


Original Secondary Outcome: Safety [ Time Frame: 40 and 60 months ]

Information By: Novartis

Dates:
Date Received: January 15, 2008
Date Started: February 2008
Date Completion:
Last Updated: October 14, 2014
Last Verified: October 2014