健康な乳児におけるジフテリア、破傷風、百日咳、不活化ポリオウイルス（DPT-IPV）ワクチン「スクエアキッズ」とGSKバイオロジカルズ社のヒトロタウイルス（HRV）ワクチン「ロタリックス」（GSK444563）の同時投与による免疫原性および安全性の評価
基本情報
- NCT ID
- NCT02907216
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 292
- 治験依頼者名
- GlaxoSmithKline
概要
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