The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
13,500
6.50 lgCCID50/ml in babies aged 18-35 months\\6.50 lgCCID50/ml in children aged 3-16 years \\6.50 lgCCID50/ml in adults aged 17 up to 65 years old
320EU/Vial in babies aged 18-35 months \\320EU/Vial in children aged 3-16 years \\640EU/Vial in adults aged 17 up to 65 years old\\boost at month 6\\two-dose
30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Institute of Medical Biology -Chinese Academy of Medical Sciences
Kunming, Yunnan, China
Changes of hepatitis A antibody concentration
Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
Time frame: 37 months
Incidence of adverse events
Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.
Time frame: 28 days
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