[Immunogenicity and safety of three consecutive lots on an inactivated hepatitis A vaccine: a double-blind, immunogenicity and safety of three consecutive lots on a inactivated hepatitis A vaccine:a double-blind, randomized and controlled trial in children].

Objective: To evaluate the immunogenicity, safety, stability and consistency of three consecutive lots of an inactivated hepatitis A vaccine (Healive).

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 or a 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 were 3237.06-3814.14 mIU/ml but were not significantly different. GMT of control vaccine was 1467.49 mIU/ml. Healive 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 were well consistent as indicated by immunogenicity and safety while immunogenicity was better than the vaccine used as control.