青少年におけるブースターとしてのBK1301（DTaPワクチン）の研究

基本情報

NCT ID: NCT02118961
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: 446
治験依頼者名: Tanabe Pharma Corporation

概要

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents. The purposes of this study are as follows: * To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies * To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

対象疾患

DiphtheriaTetanusPertussis

介入

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)(BIOLOGICAL)

Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)(BIOLOGICAL)

依頼者（Sponsor）

田辺ファーマ株式会社(INDUSTRY)

The Research Foundation For Microbial Diseases Of Osaka University(OTHER)

実施施設 (2)

Inverstigational site

Kumagaya-shi, Saitama, Japan

Inverstigational site

Shinjuku-ku, Tokyo, Japan