Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants

The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine

本研究旨在评估6~12周龄健康日本婴儿在联合或不联合接种葛兰素史克生物制品公司（GSK Biologicals）液体轮状病毒疫苗Rotarix（HRV）时，日本本土生产的白喉、破伤风、百日咳及灭活脊髓灰质炎（DPT-IPV）疫苗Squarekids的免疫原性与安全性。葛兰素史克生物制品公司的液体HRV疫苗Rotarix自2011年起在日本获批上市。尽管在HRV疫苗的临床开发阶段，已对葛兰素史克生物制品公司的DTP-IPV疫苗的联合接种方案进行了评估，但该疫苗与日本本土生产的Squarekids型DPT-IPV疫苗在成分及接种途径上均存在差异。因此，应日本监管机构要求，本次上市后研究将评估日本本土生产的DPT-IPV疫苗与液体HRV疫苗联合接种时的免疫原性。