Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults

被引：613

作者：

DiazGranados, Carlos A. ^{[1
]}

Dunning, Andrew J. ^{[1
]}

Kimmel, Murray ^{[4
]}

Kirby, Daniel ^{[1
]}

Treanor, John ^{[5
]}

Collins, Avi ^{[2
]}

Pollak, Richard ^{[6
]}

Christoff, Janet ^{[1
]}

Earl, John ^{[8
]}

Landolfi, Victoria ^{[1
]}

Martin, Earl ^{[7
]}

Gurunathan, Sanjay ^{[1
]}

Nathan, Richard ^{[9
]}

Greenberg, David P. ^{[1
,3
]}

Tornieporth, Nadia G. ^{[1
]}

Decker, Michael D. ^{[1
,10
]}

Talbot, H. Keipp ^{[11
]}

机构：

[1] Sanofi Pasteur, Swiftwater, PA 18370 USA

[2] ReS Pharmaceut Serv, Ft Washington, PA USA

[3] Univ Pittsburgh, Sch Med, Dept Pediat, Pittsburgh, PA 15261 USA

[4] Accelovance, Melbourne, FL USA

[5] Univ Rochester, Rochester, NY USA

[6] Endeavor Clin Trials, San Antonio, TX USA

[7] Martin Diagnost Clin, Tomball, TX USA

[8] PMG Res Hickory, Hickory, NC USA

[9] Idaho Falls Infect Dis & Snake River Res, Idaho Falls, ID USA

[10] Vanderbilt Univ, Sch Med, Dept Hlth Policy, Nashville, TN 37212 USA

[11] Vanderbilt Univ, Med Ctr, Nashville, TN USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2014年 / 371卷 / 07期

关键词：

UNITED-STATES; SEASONAL INFLUENZA; DOUBLE-BLIND; ELDERLY SUBJECTS; TRIAL; IMMUNOGENICITY; SAFETY; HOSPITALIZATIONS; METAANALYSIS; MORTALITY;

D O I：

10.1056/NEJMoa1315727

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND As compared with a standard-dose vaccine, a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) improves antibody responses to influenza among adults 65 years of age or older. This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness. METHODS We conducted a phase IIIb-IV, multicenter, randomized, double-blind, active-controlled trial to compare IIV3-HD (60 mu g of hemagglutinin per strain) with standard-dose trivalent, inactivated influenza vaccine (IIV3-SD [15 mu g of hemagglutinin per strain]) in adults 65 years of age or older. Assessments of relative efficacy, effectiveness, safety (serious adverse events), and immunogenicity (hemagglutination-inhibition [HAI] titers) were performed during the 2011-2012 (year 1) and the 2012-2013 (year 2) northern-hemisphere influenza seasons. RESULTS A total of 31,989 participants were enrolled from 126 research centers in the United States and Canada (15,991 were randomly assigned to receive IIV3-HD, and 15,998 to receive IIV3-SD). In the intention-to-treat analysis, 228 participants in the IIV3-HD group (1.4%) and 301 participants in the IIV3-SD group (1.9%) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness (relative efficacy, 24.2%; 95% confidence interval [CI], 9.7 to 36.5). At least one serious adverse event during the safety surveillance period was reported by 1323 (8.3%) of the participants in the IIV3-HD group, as compared with 1442 (9.0%) of the participants in the IIV3-SD group (relative risk, 0.92; 95% CI, 0.85 to 0.99). After vaccination, HAI titers and seroprotection rates (the percentage of participants with HAI titers >= 1:40) were significantly higher in the IIV3-HD group. CONCLUSIONS Among persons 65 years of age or older, IIV3-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3-SD.

引用

页码：635 / 645

页数：11

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