This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
All subjects had blood drawn at Day 1 and Day 29.
All subjects had blood drawn at Day 1 and Day 29.
Department of Pediatrics, Kosin University Gospel Hospital
Busan, South Korea
Department of Pediatrics, Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Deaprtment of Pediatrics, Inha University Hospital
Incheon, South Korea
Percentages of 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 response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as: 1. for subjects with a pre-vaccination hSBA titer \< 1:4, a postvaccination hSBA titer ≥ 1:8. 2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time frame: day 29
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Time frame: day 1 and day 29
Percentages 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, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Time frame: day 1 and day 29
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
Time frame: during 7 days of vaccination
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Division of Infectious Diseases, Inha University Hospital
Incheon, South Korea
Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University
Kyunggi, South Korea
Department of Pediatrics, Ewha Womans University Mokdong Hospital
Seoul, South Korea
Division of Infection Diseases, Seoul National University Hospital
Seoul, South Korea
Division of Infectious Diseases, Korea University Guro Hospital
Seoul, South Korea