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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
382
Blood test, 40-months and 60-months children
Blood test, 40-months and 60-months children
Clinical Trials Research Center
Halifax, Canada
Vaccine Evaluation Center
Vancouver, Canada
Oxford Vaccine Group
Oxford, United Kingdom
Percentage of Subjects With hSBA ≥1:8
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.
Time frame: At 40 and 60 months of age
Percentage of Subjects With hSBA ≥1:4
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.
Time frame: At 40 and 60 months of age
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
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.
Time frame: At 40 and 60 months of age
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