The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,537
3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Number of subjects with adverse events
To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Time frame: Within 28 days after hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Time frame: The 28th day after whole course of hepatitis B vaccination
The rate of hepatitis B virus perinatal transmission
To analyze the rate of hepatitis B virus perinatal transmission after whole course of hepatitis B vaccination.
Time frame: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Time frame: The 28th day after the second of hepatitis B vaccination
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