Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)

Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Timeline

Start

2015-11

Primary completion

2016-02

Completion

2016-02

Publications

• Results Anh DD, Thiem VD, Anh NTH, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, Wahid R, Flores J, Berlanda Scorza F, Taylor DN. Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults. Vaccine. 2016 Oct 26;34(45):5457-5462. doi: 10.1016/j.vaccine.2016.08.052. Epub 2016 Aug 24.

Drugs

Indications