GSKバイオロジカルズのヒトロタウイルス（HRV）ワクチン（444563）2製剤の免疫原性および安全性評価（生後6～12週の健康な乳児を対象に実施）

基本情報

NCT ID

NCT02914184

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,612

治験依頼者名

GlaxoSmithKline

概要

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

対象疾患

介入

依頼者（Sponsor）