日本人乳幼児におけるロタリックスワクチンの有効性、安全性、反応原性および免疫原性

基本情報

NCT ID

NCT00480324

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

765

治験依頼者名

GlaxoSmithKline

概要

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

対象疾患

介入

依頼者（Sponsor）