The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months. For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
119
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, South Korea
The Catholic University of Korea, St.Vincent's Hospital.
Suwon, Gyeonggi-do, South Korea
Korea University Ansan Hospital
Ansan, South Korea
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
Time frame: 1 month after the second administration of the investigational product
Antibody titer (GMT)
The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination
Time frame: 1 month after the second vaccination
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