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Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults
Open accessAbstract
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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“for some populations, such as older adults, a higher dose might be beneficial, as has been shown for the influenza vaccine69,70.”
From A guide to vaccinology: from basic principles to new developments (2021) · cites this paper as [70]
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Metadata
- 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)
- 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
- 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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