健康な若年成人を対象とした組換え型インフルエンザH5N1ワクチンの免疫原性、安全性および最適投与量探索試験

基本情報

NCT ID

NCT00980447

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

90

治験依頼者名

UMN Pharma Inc.

概要

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)