Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

本研究将评估葛兰素史克生物制品公司（GSK Biologicals）2189242A号肺炎球菌疫苗不同配方的安全性、反应原性与免疫原性。该疫苗可单独接种，或与10价肺炎球菌结合疫苗（10-valent pneumococcal conjugate vaccine，GSK1024850A疫苗）联合接种，针对首次接种时年龄为12~23月龄的健康儿童，采用2剂次基础免疫程序后追加1剂加强针的接种方案。鉴于肺炎球菌疫苗（通常与其他儿科常规疫苗联合接种）接种后常出现发热反应，本研究的主要研究目标将聚焦于评估3级发热（即直肠体温＞40.0℃）的发生率增幅。