tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2019 Feb 19. doi: 10.1080/21645515.2019.1581541. [Epub ahead of print]
[h=1]Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study.[/h] Hu Y[SUP]1[/SUP], Chu K[SUP]1[/SUP], Lavis N[SUP]2[/SUP], Li X[SUP]3[/SUP], Liang B[SUP]3[/SUP], Liu S[SUP]4[/SUP], Shao M[SUP]4[/SUP], Shu JD[SUP]2[/SUP], Tabar C[SUP]2[/SUP], Samson S[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] 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.
[h=4]KEYWORDS:[/h] China; Trivalent influenza vaccines; immunogenicity; influenza; reactogenicity; safety; vaccination
PMID: 30779689 DOI: 10.1080/21645515.2019.1581541
[h=1]Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study.[/h] Hu Y[SUP]1[/SUP], Chu K[SUP]1[/SUP], Lavis N[SUP]2[/SUP], Li X[SUP]3[/SUP], Liang B[SUP]3[/SUP], Liu S[SUP]4[/SUP], Shao M[SUP]4[/SUP], Shu JD[SUP]2[/SUP], Tabar C[SUP]2[/SUP], Samson S[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] 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.
[h=4]KEYWORDS:[/h] China; Trivalent influenza vaccines; immunogenicity; influenza; reactogenicity; safety; vaccination
PMID: 30779689 DOI: 10.1080/21645515.2019.1581541