Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan

Summary

The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population. Primary objectives: * To describe the safety profile of all subjects who receive at least 1 injection * To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.

Timeline

Start

2013-07

Primary completion

2013-10

Completion

2014-06

Publications

• Results Matsuoka O, Patel DM, Sasaki S, Oka H, Sasaki T, Pietrobon PJ, Laot T, Bouckenooghe A, Menezes J, de Bruyn G. Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. Hum Vaccin Immunother. 2018 Feb 1;14(2):322-328. doi: 10.1080/21645515.2017.1395538. Epub 2017 Dec 6.

Drugs

Indications