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[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]

Author(s): Jiang WP, Wang YL, Chen WY, Xu WG, Chen JT, Wang X, Liu Y, Yin WD

Affiliation(s): Changzhou Center for Disease Control and Prevention, Changzhou 213003, China.

Publication date & source: 2008-06, Zhonghua Liu Xing Bing Xue Za Zhi., 29(6):556-9.

Publication type: English Abstract; Randomized Controlled Trial

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.

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