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Efficacy of high-dose versus standard-dose influenza vaccine in older adults.
- Source :
-
The New England journal of medicine [N Engl J Med] 2014 Aug 14; Vol. 371 (7), pp. 635-45. - Publication Year :
- 2014
-
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.<br />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.<br />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.).
- Subjects :
- Aged
Antibodies, Viral blood
Chronic Disease
Double-Blind Method
Female
Humans
Influenza Vaccines adverse effects
Influenza Vaccines immunology
Influenza, Human immunology
Intention to Treat Analysis
Male
Orthomyxoviridae immunology
Vaccines, Inactivated administration & dosage
Vaccines, Inactivated immunology
Influenza Vaccines administration & dosage
Influenza, Human prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 371
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 25119609
- Full Text :
- https://doi.org/10.1056/NEJMoa1315727