Dataset from Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

本研究旨在评估15~18月龄受试者接种白喉-破伤风-全细胞百日咳-乙型肝炎病毒/b型流感嗜血杆菌联合疫苗（DTPw-HBV/Hib）加强针的安全性与反应原性，同时评估24至30月龄时已完成基础免疫的受试者接种Mencevax™ A、C、W135群多糖脑膜炎球菌疫苗（ACW）的免疫原性、安全性及反应原性。本研究的试验方案公示内容已更新，以符合2007年9月《FDA修订法案》的相关要求。