The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval). This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
106
Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Anti-HAV seroconversion rate at 4 weeks after the second vaccination
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV \< 20 mIU/mL at baseline
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
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