tetano
Editor, Senior Moderator
Vaccine
. 2022 Oct 7;S0264-410X(22)01200-2.
doi: 10.1016/j.vaccine.2022.09.078. Online ahead of print.
Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study
Jau-Yuan Chen[SUP] 1 [/SUP], Szu-Min Hsieh[SUP] 2 [/SUP], Shinn-Jang Hwang[SUP] 3 [/SUP], Chiu-Shong Liu[SUP] 4 [/SUP], Xiaoling Li[SUP] 5 [/SUP], Marion Fournier[SUP] 6 [/SUP], Ting-Yu Yeh[SUP] 7 [/SUP], J Kevin Yin[SUP] 8 [/SUP], Sandrine I Samson[SUP] 6 [/SUP]
Affiliations
Abstract
Background: High-dose influenza vaccine offers better protection against influenza/associated complications compared with standard-dose formulation. We evaluated immunogenicity and safety of high-dose influenza vaccine (QIV-HD) and standard-dose (QIV-SD) in older adults (≥ 65 years) in Taiwan.
Methods: This was a phase III, randomized, modified double-blind, active-controlled, multi-center, descriptive study in older adults. Participants (N = 165) were randomized 1:1 to receive QIV-HD or QIV-SD vaccine (clinicaltrials.gov#NCT04537234).
Results: For all four influenza strains, geometric means titers (GMTs) of hemagglutination inhibition were higher for the QIV-HD than QIV-SD with adjusted GMT ratios (95 % CI) of 2.65 (1.87-3.75) for A/H1N1; 1.76 (1.31-2.38) for A/H3N2; 2.60 (1.90-3.56) for B/Victoria; and 2.01 (1.57-2.56) for B/Yamagata. The seroconversion was higher for QIV-HD than QIV-SD with similar safety profiles across both groups.
Conclusion: QIV-HD was highly immunogenic for four influenza strains and have acceptable safety profile in older adults aged ≥ 65 years in Taiwan.
Keywords: Clinical study; High dose quadrivalent influenza vaccine; Immunogenicity; Older adults; Safety; Taiwan.
. 2022 Oct 7;S0264-410X(22)01200-2.
doi: 10.1016/j.vaccine.2022.09.078. Online ahead of print.
Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study
Jau-Yuan Chen[SUP] 1 [/SUP], Szu-Min Hsieh[SUP] 2 [/SUP], Shinn-Jang Hwang[SUP] 3 [/SUP], Chiu-Shong Liu[SUP] 4 [/SUP], Xiaoling Li[SUP] 5 [/SUP], Marion Fournier[SUP] 6 [/SUP], Ting-Yu Yeh[SUP] 7 [/SUP], J Kevin Yin[SUP] 8 [/SUP], Sandrine I Samson[SUP] 6 [/SUP]
Affiliations
- PMID: 36216650
- DOI: 10.1016/j.vaccine.2022.09.078
Abstract
Background: High-dose influenza vaccine offers better protection against influenza/associated complications compared with standard-dose formulation. We evaluated immunogenicity and safety of high-dose influenza vaccine (QIV-HD) and standard-dose (QIV-SD) in older adults (≥ 65 years) in Taiwan.
Methods: This was a phase III, randomized, modified double-blind, active-controlled, multi-center, descriptive study in older adults. Participants (N = 165) were randomized 1:1 to receive QIV-HD or QIV-SD vaccine (clinicaltrials.gov#NCT04537234).
Results: For all four influenza strains, geometric means titers (GMTs) of hemagglutination inhibition were higher for the QIV-HD than QIV-SD with adjusted GMT ratios (95 % CI) of 2.65 (1.87-3.75) for A/H1N1; 1.76 (1.31-2.38) for A/H3N2; 2.60 (1.90-3.56) for B/Victoria; and 2.01 (1.57-2.56) for B/Yamagata. The seroconversion was higher for QIV-HD than QIV-SD with similar safety profiles across both groups.
Conclusion: QIV-HD was highly immunogenic for four influenza strains and have acceptable safety profile in older adults aged ≥ 65 years in Taiwan.
Keywords: Clinical study; High dose quadrivalent influenza vaccine; Immunogenicity; Older adults; Safety; Taiwan.