Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children

被引：12

作者：

Brady, Rebecca C. ^{[1
]}

Hu, Wilson ^{[2
]}

Houchin, Vonda G. ^{[3
]}

Eder, Frank S. ^{[4
]}

Jackson, Kenneth C. ^{[5
]}

Hartel, Gunter F. ^{[2
]}

Sawlwin, Daphne C. ^{[2
]}

Albano, Frank R. ^{[2
]}

Greenberg, Michael ^{[2
]}

机构：

[1] Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA

[2] CSL Ltd, Melbourne, Vic, Australia

[3] Harrisburg Family Med Ctr, Harrisburg, AR USA

[4] United Hlth Serv, Binghamton, NY USA

[5] Grand Prairie Pediat & Allergy Clin, Warr Acres, OK USA

来源：

VACCINE | 2014年 / 32卷 / 52期

关键词：

Trivalent inactivated influenza vaccine; Children; Safety; Fever;

D O I：

10.1016/j.vaccine.2014.10.024

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

A trivalent inactivated influenza vaccine (CSL's TIV, CSL Limited) was licensed under USA accelerated approval regulations for use in persons >= 18 years. We performed a randomized, observer-blind study to assess the safety and immunogenicity of CSL's TIV versus an established US-licensed vaccine in a population >= 6 months to <18 years of age. Subjects were stratified as follows: Cohort A (>= 6 months to <3 years); Cohort B (>= 3 years to <9 years); and Cohort C (>= 9 years to <18 years). The subject's age and influenza vaccination history determined the dosing regimen (one or two vaccinations). Subjects received CSL's TIV (n=739) or the established vaccine (n=735) in the autumn of 2009. Serum hemagglutination-inhibition titers were determined pre-vaccination and 30 days after the last vaccination. No febrile seizures or other vaccine-related SAEs were reported. After the first vaccination for Cohorts A and B, respectively, the relative risks of fever were 2.73 and 2.32 times higher for CSL's TIV compared to the established vaccine. Irritability and loss of appetite (for Cohort A) and malaise (for Cohort B) were also significantly higher for CSL's TIV compared to the established vaccine. Post-vaccination geometric mean titers (GMTs) for CSL's TIV versus the established vaccine were 385.49 vs. 382.45 for H1N1; 669.13 vs. 705.61 for H3N2; and 100.65 vs. 93.72 for B. CSL's TIV demonstrated immunological non-inferiority to the established vaccine in all cohorts. (C) 2014 Elsevier Ltd. All rights reserved.

引用

页码：7141 / 7147

页数：7

共 20 条

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