Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study.
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| 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 ratio to receive a single 0.5-mL intramuscular injection of the 2017-2018 Northern Hemisphere formulation of Shz-IIV3 (n = 800) or the comparator IIV3 (n = 799). Between baseline and day 28 after vaccination, hemagglutination inhibition titers for the three vaccine strains increased by at least 4-fold and were of similar magnitude in Shz-IIV3 and comparator IIV3 recipients. The rate of seroconversion or significant increase in titers was 62% to 92% in Shz-IIV3 recipients, and 63% to 91% in comparator IIV3 recipients. Post-vaccination hemagglutination inhibition titers and seroconversion rates for Shz-IIV3 were statistically non-inferior to the comparator IIV3 for all three influenza vaccine strains. Rates of solicited and unsolicited vaccine-related adverse events were similar between the two vaccine groups. These results demonstrated that Shz-IIV3 was as immunogenic and safe in adults as a comparator Chinese IIV3, and support the continued use of Shz-IIV3 in China.
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| Authors | Yuemei Hu, Kai Chu, Nathalie Lavis, Xiaoling Li, Bill Liang, Shuzhen Liu, Ming Shao, Jean-Denis Shu, Cynthia Tabar, Sandrine Samson |
| Journal | Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 15 Issue 5 Pg. 1066-1069 ( 2019) ISSN: 2164-554X [Electronic] United States |
| PMID | 30779689 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
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