Immunogenicity and safety of three consecutive lots on a inactivated hepatitis A vaccine: a double-blind,randomized and controlled trial in children / 中华流行病学杂志

ABSTRACT

Objective To evaluate the immunogenicity, safety, stability and consistency of three consecutive lots of a inactivated hepatitis A vaccine (Healive(R)). Methods A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers aged from 1 to 8 years. Totally, 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive(R) or an licensed control vaccine in 0 and 6th month. Safety was assessed through a 30 minutes and three days observation,thereafter. Anti-HAV titers were determined on the 1st, 6th and 7th month after the vaccination.Results Seroconversion rate of four groups were all 100% by the end of the schedule while GMTs of Healive(R) were 3237.06-3814.14 mIU/ml but were not significantly different. GMT of control vaccine was 1467.49 mIU/ml. Healive(R) and control vaccine were well tolerated with 1%-5% incidence of overall adverse reactions in which most of them were mild and moderate. No severe adverse reaction was reported.Conclusion The three consecutive lots of Healive(R) were well consistent as indicated by immunogenicity and safety while immunogenicity was better than the vaccine used as control.