This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
341
All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
Mackay Memorial Hospital,
Taipei, Taiwan, China
National Taiwan University Hospital
Taipei, Taiwan, China
Far Eastern Memorial Hospital,
Taipei, Taiwan, China
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: Day 1 and Day 29
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: Day 1 and Day 29
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Time frame: Day 1 and 29
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
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Time frame: Day 1 and Day 29
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
Time frame: Day 1 and 29
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
Time frame: From day 1 through day 7 postvaccination
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
Time frame: From day 1 through day 7 postvaccination