ATN 025 Vaccination Follow Up Summary Form: Adverse Events Reported [CRF 13] Dataset in Hepatitis B Vaccination in Youth at Adolescent Trials Network Sites: Effectiveness of Two Strategies and Evaluation of Tools to be Used in Future HIV Prevention Trials

Data from Vaccination Follow Up Summary Form: Adverse Events Reported [CRF 13]
Study Description
A randomized, single-blinded trial evaluating two licensed vaccine products, Recombivax and Twinrix, given in a two-dose schedule to youth at risk for HIV and hepatitis B infection. Primary objectives were to determine immunogenicity of the products in the study population and to determine safety and tolerability of the vaccines given in the two regimens.
HIV and hepatitis B negative youth aged 12 to 17

疫苗接种随访总结表数据：报告的不良事件 [病例报告表（Case Report Form, CRF）13]
研究概况
本研究为一项随机单盲临床试验，旨在评估两款获批上市的疫苗产品——重组乙型肝炎疫苗（Recombivax）与双价乙型肝炎疫苗（Twinrix）——以两剂次接种方案给药于HIV及乙型肝炎病毒感染高风险青少年的效果。主要研究目标为明确两款疫苗在本研究人群中的免疫原性，同时评估两种接种方案下疫苗的安全性与耐受性。
研究对象为12至17岁、HIV及乙型肝炎病毒检测阴性的青少年。