Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study.

ABSTRACT: Seasonal influenza causes substantial morbidity and mortality in China, which largely results from limited vaccine accessibility and poor vaccination coverage. Since 2013, Sanofi Pasteur's facilities in Shenzhen, China have produced a trivalent inactivated influenza vaccine (Shz-IIV3) for each influenza season according to Chinese pharmacopeia requirements. However, the immunogenicity of Shz-IIV3 has not been compared to existing Chinese trivalent inactivated influenza vaccines (IIV3s). Here, we describe the results of a phase IV, observer-blind, randomized study to evaluate whether the immunogenicity of Shz-IIV3 was non-inferior to a comparator IIV3 (Hualan Biological Engineering Inc) also manufactured and licensed in China. Healthy adults aged 18-59 years were randomly assigned in a 1:1

SUBMITTER: Hu Y 

PROVIDER: S-EPMC6605815 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature