The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,738
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Center for Disease Control and Prevention Jiangsu Province
Nanjing, Jiangsu, China
Seroconversion rate for subjects in Stratum 2
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.
Time frame: Month 7
Positivity for HBsAg for subjects in Stratum 1
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
Time frame: Month 2, Month 7 and Month 12
Seroconversion rate for subjects in Stratum 1
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Time frame: Month 7
Solicited adverse events
Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever \[body temperature ≥38°C\]
Time frame: Days 1 to 4
Seroconversion rate for subjects in Stratum 1
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Time frame: Month 12
Positivity for HBsAg for subjects in Stratum 2
Time frame: Months 2, 7 and 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.