The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.
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
253
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, South Korea
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
Time frame: 1 month after the second vaccination
Seroconversion rate
Seroconversion rate at 1 month after the first vaccination
Time frame: 1 month after the first vaccination
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The Catholic University of Korea,Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
The Catholic University of Korea,Yeouido St.Mary's Hospital
Seoul, Yeongdeungpo-gu, South Korea
Hallym University Medical Center
Seoul, Yeongdeungpo-gu, South Korea
Soon chung hyang university hospita
Bucheon-si, South Korea
Inje university Ilsan Paik hospital
Ilsan, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Hanyang university medical center
Seoul, South Korea
...and 2 more locations