Cited by 878Influenza Virus Research StudiesRespiratory viral infections researchBacterial Infections and Vaccines

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

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DiazGranados, Carlos A., Dunning, Andrew J., Kimmel, Murray, Kirby, Daniel, Treanor, John, Collins, Avi, Pollak, Richard, Christoff, Janet, Earl, John, Landolfi, Victoria, Martin, Earl, Gurunathan, Sanjay, Nathan, Richard, Greenberg, David P., Tornieporth, Nadia G., Decker, Michael D., Talbot, H. Keipp·2014·New England Journal of Medicine

DOI 10.1056/nejmoa1315727

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Abstract

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 μg of hemagglutinin per strain) with standard-dose trivalent, inactivated influenza vaccine (IIV3-SD [15 μg 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. (Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01427309.).

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Authors: DiazGranados, C. A., Dunning, A. J., Kimmel, M., Kirby, D., Treanor, J., Collins, A., Pollak, R., Christoff, J., Earl, J., Landolfi, V., Martin, E., Gurunathan, S., Nathan, R., Greenberg, D. P., Tornieporth, N. G., Decker, M. D., & Talbot, H. K.
Affiliations: University of Pittsburgh (US)
University of Rochester (US)
PMG Research (US)
Martin Diagnostic Clinic (US)
Vanderbilt University (US)
Vanderbilt University Medical Center (US)
ORCID: Dunning, Andrew J.
Gurunathan, Sanjay
Decker, Michael D.
Talbot, H. Keipp
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2014-08-14
Volume: 371
Issue: 7
Pages: 635-645
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1315727
OpenAlex: W2168805652
Cited by: 876
References: 29
Citations by year: 2026: 76 · 2025: 89 · 2024: 60 · 2023: 78 · 2022: 68 · 2021: 95 · 2020: 80 · 2019: 78 · 2018: 68 · 2017: 65 · 2016: 65 · 2015: 42 · 2014: 10
FWCI: 45.92
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords: high-dose influenza vaccine, trivalent inactivated influenza vaccine, older adults, vaccine efficacy, laboratory-confirmed influenza, hemagglutination inhibition titers, immunogenicity, seroprotection, serious adverse events, influenza vaccination, 2011-2012 influenza season, 2012-2013 influenza season, antibody response
MeSH terms: Aged, Antibodies, Viral, Chronic Disease, Double-Blind Method, Female, Humans, Influenza, Human, Influenza Vaccines, Male, Orthomyxoviridae, Vaccines, Inactivated, Intention to Treat Analysis

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

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