An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

Summary

An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects

Timeline

Start

2010-12

Primary completion

2013-04

Completion

2013-04

Outcome

Met primary endpoint

release “IC84 showed a favorable safety and tolerability profile (primary objectives) in both study populations, elderly subjects and adults.” valneva.com ↗

Publications

• Bezay N, Ayad A, Dubischar K, Firbas C, Hochreiter R, Kiermayr S, Kiss I, Pinl F, Jilma B, Westritschnig K. Safety, immunogenicity and dose response of VLA84, a new vaccine candidate against Clostridium difficile, in healthy volunteers. Vaccine. 2016 May 17;34(23):2585-92. doi: 10.1016/j.vaccine.2016.03.098. Epub 2016 Apr 11.

Drugs

Indications