The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008. This study is the fifth-year follow-up research for the previous clinical trial.
Study Type
OBSERVATIONAL
Enrollment
332
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Tianjin center for disease prevention and control
Tianjin, China
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
to evaluate the immune persistence of anti-HAV antibodies in serum
Time frame: 60 months after vaccination
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