A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months

This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

本研究旨在评估Hib-MenCY-TT联合疫苗的安全性与免疫原性，并与接种获批上市的b型流感嗜血杆菌（Hib）结合疫苗或C群脑膜炎球菌（MenC）结合疫苗的对照组进行比较，所有受试疫苗均于受试者2、4、6及12至15月龄时接种。在加强针接种阶段，本研究将评估该疫苗与减毒麻疹腮腺炎风疹联合疫苗、减毒水痘疫苗的联合接种情况。本研究方案已完成更新，以符合2007年9月出台的《美国食品药品监督管理局修订法案》（FDA Amendment Act）。