Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults

被引：95

作者：

Greenberg, David P. ^{[1
]}

Robertson, Corwin A. ^{[1
]}

Noss, Michael J. ^{[2
]}

Blatter, Mark M. ^{[3
]}

Biedenbender, Rex ^{[4
]}

Decker, Michael D. ^{[1
]}

机构：

[1] Sanofi Pasteur, Swiftwater, PA 18370 USA

[2] Radiant Res, Cincinnati, OH 45249 USA

[3] Primary Phys Res, Pittsburgh, PA 15241 USA

[4] Eastern Virginia Med Sch, Norfolk, VA 23507 USA

来源：

VACCINE | 2013年 / 31卷 / 05期

关键词：

Influenza vaccine; Quadrivalent; Immunogenicity; Safety; Adults; United States; IMMUNE-RESPONSE; VIRUS;

D O I：

10.1016/j.vaccine.2012.11.074

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Purpose: To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two influenza B strains, one of each lineage, compared with licensed trivalent inactivated influenza vaccines (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a Yamagata B-lineage strain (2008-2009 TIV). Methods: Healthy adults >= 18 years of age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted in the US. Participants received a single dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 days after vaccine administration to test for hemagglutination inhibition (HAI) antibodies to each of the four influenza strains. Immunogenicity end-points included geometric mean HAI antibody titers (GMTs) and rates of seroprotection (titer >= 1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety endpoints included frequency of solicited injection-site and systemic reactions occurring within 3 days of vaccination, and unsolicited non-serious adverse events (AEs) and serious AEs (SAEs) within 21 days of vaccination. Results: One hundred and ninety participants were enrolled to each vaccine group. QIV induced GMTs to each A and B strain that were noninferior to those induced by the 2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence interval of the ratio of GMT(QIV)/GMT(TIV) > 0.66 for each strain). Rates of seroprotection and seroconversion were similar in all groups. Incidence and severity of solicited injection-site and systemic reactions, AEs, and SAEs were similar among groups. Conclusion: QIV, containing two B strains (one from each B lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to be a useful alternative to TIV and offer protection against both B lineages. (C) 2012 Elsevier Ltd. All rights reserved.

引用

页码：770 / 776

页数：7

共 18 条

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