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本文对SmithKline Beecham公司研制的甲型肝炎灭活疫苗在2～4岁健康儿童中的耐受性和免疫原性作一评价。 研究对象为30名2～4岁健康儿童。接种剂量是成人的一半(即360mIU/ml),三角肌区注射,隔月接种,共2次,随后在第6个月时加强接种1次。对所有试验儿童在首次接种前4周,接种后第25天及第2、6和7个月作临床和生物学检查,测定天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)含量及抗-HAV滴度。接种当天和随后3天,由家长记录局部反应(疼痛、硬结、红斑和渗液)和/或全身反应(发热、头痛、食欲不振、恶心和呕
This article reviews the tolerability and immunogenicity of Hepatitis A inactivated vaccine developed by SmithKline Beecham in healthy children aged 2 to 4 years. The subjects were 30 healthy children aged 2 to 4 years old. Inoculation dose is half adult (ie, 360 mIU / ml), deltoid area injection, vaccination every other month, a total of 2 times, followed by intensive vaccination at 6 months. All children were tested for clinical and biological status at 4 weeks prior to the first vaccination, 25 days and 2, 6 and 7 months after inoculation, and the levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) And anti-HAV titer. On the day of inoculation and 3 days thereafter, the parents recorded local reactions (pain, induration, erythema and effusion) and / or systemic reactions (fever, headache, loss of appetite, nausea and vomiting