Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study

被引：3

作者：

Chen, Jau-Yuan ^{[1
,2
]}

Hsieh, Szu-Min ^{[3
]}

Hwang, Shinn-Jang ^{[4
,5
]}

Liu, Chiu-Shong ^{[6
]}

Li, Xiaoling ^{[7
]}

Fournier, Marion ^{[8
]}

Yeh, Ting-Yu ^{[9
]}

Yin, J. Kevin ^{[7
,10
]}

Samson, Sandrine, I ^{[8
]}

机构：

[1] Chang Gung Mem Hosp, Linkou Branch, Taoyuan, Taiwan

[2] Chang Gung Univ, Coll Med, Taoyuan, Taiwan

[3] Natl Taiwan Univ Hosp, Taipei, Taiwan

[4] Taipei Vet Gen Hosp, Taipei, Taiwan

[5] Natl Yang Ming Chiao Tung Univ, Sch Med, Taipei, Taiwan

[6] China Med Univ Hosp, Taichung, Taiwan

[7] Sanofi, 38 Beach Rd,18-11 South Beach Tower, Singapore 189767, Singapore

[8] Sanofi, Lyon, France

[9] Sanofi, Taipei, Taiwan

[10] Univ Sydney, Fac Med & Hlth, Sydney, NSW, Australia

来源：

VACCINE | 2022年 / 40卷 / 45期

关键词：

Immunogenicity; Safety; High dose quadrivalent influenza vaccine; Older adults; Clinical study; Taiwan; MORTALITY; EFFICACY;

D O I：

10.1016/j.vaccine.2022.09.078

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: High-dose influenza vaccine offers better protection against influenza/associated complica-tions 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. CO 2022 Published by Elsevier Ltd.

引用

页码：6450 / 6454

页数：5

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